**CDC [Institutional Review Board
(IRB)]{.smallcaps}**![](media/image1.wmf){width="0.7152777777777778in"
height="0.47638888888888886in"}

**[Request for Continuing Review of Protocol]{.smallcaps}**

+-------------------------+---+----+---+----+--------------------------+
| **Date Received in      |   |    | * |    |                          |
| HSA:     **             |   |    | * |    |                          |
|                         |   |    | P |    |                          |
|                         |   |    | r |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | t |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | c |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | l |    |                          |
|                         |   |    | N |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | . |    |                          |
|                         |   |    | : |    |                          |
|                         |   |    | 2 |    |                          |
|                         |   |    | 5 |    |                          |
|                         |   |    | 8 |    |                          |
|                         |   |    | 8 |    |                          |
|                         |   |    | * |    |                          |
|                         |   |    | * |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Instructions:** Use   |   |    |   |    |                          |
| this form when          |   |    |   |    |                          |
| submitting protocols    |   |    |   |    |                          |
| for continuing IRB      |   |    |   |    |                          |
| review. Review is       |   |    |   |    |                          |
| required AT LEAST       |   |    |   |    |                          |
| annually; however, the  |   |    |   |    |                          |
| IRB may have determined |   |    |   |    |                          |
| that your protocol will |   |    |   |    |                          |
| need to be reviewed     |   |    |   |    |                          |
| more often. To          |   |    |   |    |                          |
| facilitate rapid        |   |    |   |    |                          |
| processing, please      |   |    |   |    |                          |
| submit this form        |   |    |   |    |                          |
| electronically along    |   |    |   |    |                          |
| with supporting         |   |    |   |    |                          |
| documents to your CIO   |   |    |   |    |                          |
| Human Subjects Contact  |   |    |   |    |                          |
| (HSC). However, if      |   |    |   |    |                          |
| submitting hard copies, |   |    |   |    |                          |
| please send the         |   |    |   |    |                          |
| original and two copies |   |    |   |    |                          |
| of all documents to HSA |   |    |   |    |                          |
| through your HSC.       |   |    |   |    |                          |
| Consecutively number    |   |    |   |    |                          |
| **ALL** pages,          |   |    |   |    |                          |
| beginning with the      |   |    |   |    |                          |
| protocol title page (if |   |    |   |    |                          |
| applicable), followed   |   |    |   |    |                          |
| by consent form(s) and  |   |    |   |    |                          |
| any applicable          |   |    |   |    |                          |
| ancillary documents.    |   |    |   |    |                          |
| Complete all applicable |   |    |   |    |                          |
| items or the form will  |   |    |   |    |                          |
| be returned.            |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Protocol Title:**     |   |    |   |    |                          |
| Intensive               |   |    |   |    |                          |
| Pharmacokinetic Study   |   |    |   |    |                          |
| of Intermittent         |   |    |   |    |                          |
| Rifabutin and Isoniazid |   |    |   |    |                          |
| with Daily Efavirenz in |   |    |   |    |                          |
| Combination with Two    |   |    |   |    |                          |
| Nucleoside Analogs for  |   |    |   |    |                          |
| Treatment of HIV and    |   |    |   |    |                          |
| Tuberculosis            |   |    |   |    |                          |
| Co-infections           |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Proposed Project      |   | ** |   |    | **End:**  11/05          |
| Dates**                 |   | Be |   |    |                          |
|                         |   | gi |   |    |                          |
|                         |   | n: |   |    |                          |
|                         |   | ** |   |    |                          |
|                         |   | 1  |   |    |                          |
|                         |   | 1/ |   |    |                          |
|                         |   | 99 |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Name of Primary CDC   |   |    |   |    | **Degrees:** MD, MHS     |
| Contact (P.I.):**       |   |    |   |    |                          |
| Andrew Vernon           |   |    |   |    |                          |
|                         |   |    |   |    |                          |
| **Check if P.I. has     |   |    |   |    |                          |
| changed**               |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| ***Scientific Ethics*   |   |    |   |    | **CDC User               |
| Verification No.:       |   |    |   |    | ID: anv3    **           |
| 0108**                  |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **CIO: NCHSTP    **     | * |    |   |    | **MS: E-07    **         |
|                         | * |    |   |    |                          |
|                         | D |    |   |    |                          |
|                         | i |    |   |    |                          |
|                         | v |    |   |    |                          |
|                         | i |    |   |    |                          |
|                         | s |    |   |    |                          |
|                         | i |    |   |    |                          |
|                         | o |    |   |    |                          |
|                         | n |    |   |    |                          |
|                         | : |    |   |    |                          |
|                         |   |    |   |    |                          |
|                         | O |    |   |    |                          |
|                         | D |    |   |    |                          |
|                         |   |    |   |    |                          |
|                         |   |    |   |    |                          |
|                         | * |    |   |    |                          |
|                         | * |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Tel                   |   |    |   |    | **FAX: 404-639-8961 **   |
| ephone: 404-639-8123 ** |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **List all CDC          |   |    |   |    |                          |
| Co-investigators (use   |   |    |   |    |                          |
| supplemental page if    |   |    |   |    |                          |
| necessary):**           |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **1*.***[M. Elsa        |   |    |   | *  |                          |
| Villarino, MD,          |   |    |   | ** |                          |
| MPH]                    |   |    |   | Sc |                          |
| {.underline}***     *** |   |    |   | ie |                          |
|                         |   |    |   | nt |                          |
|                         |   |    |   | if |                          |
|                         |   |    |   | ic |                          |
|                         |   |    |   | E  |                          |
|                         |   |    |   | th |                          |
|                         |   |    |   | ic |                          |
|                         |   |    |   | s* |                          |
|                         |   |    |   | Ve |                          |
|                         |   |    |   | ri |                          |
|                         |   |    |   | fi |                          |
|                         |   |    |   | ca |                          |
|                         |   |    |   | ti |                          |
|                         |   |    |   | on |                          |
|                         |   |    |   | No |                          |
|                         |   |    |   | .: |                          |
|                         |   |    |   | 18 |                          |
|                         |   |    |   | 23 |                          |
|                         |   |    |   | ** |                          |
+-------------------------+---+----+---+----+--------------------------+
| **2.** [Lorna Bozeman,  |   |    |   | *  |                          |
| MS]{.underline}         |   |    |   | ** |                          |
|                         |   |    |   | Sc |                          |
|                         |   |    |   | ie |                          |
|                         |   |    |   | nt |                          |
|                         |   |    |   | if |                          |
|                         |   |    |   | ic |                          |
|                         |   |    |   | E  |                          |
|                         |   |    |   | th |                          |
|                         |   |    |   | ic |                          |
|                         |   |    |   | s* |                          |
|                         |   |    |   | Ve |                          |
|                         |   |    |   | ri |                          |
|                         |   |    |   | fi |                          |
|                         |   |    |   | ca |                          |
|                         |   |    |   | ti |                          |
|                         |   |    |   | on |                          |
|                         |   |    |   | No |                          |
|                         |   |    |   | .: |                          |
|                         |   |    |   | 1  |                          |
|                         |   |    |   | 79 |                          |
|                         |   |    |   | 08 |                          |
|                         |   |    |   | ** |                          |
+-------------------------+---+----+---+----+--------------------------+
| **1. Current            |   |    |   |    |                          |
| Status:     **          |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| xxxActive research with |   |    |   |    |                          |
| subjects completed;     |   |    |   |    |                          |
| study activities        |   |    |   |    |                          |
| involve only data       |   |    |   |    |                          |
| analysis and/or report  |   |    |   |    |                          |
| writing (complete items |   |    |   |    |                          |
| 2,4,5,6,7,8, & 10).     |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **2. Study Population** |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_0\_\_\_ Enrolled    |   |    |   | *  |                          |
| this past year          |   |    |   | *F |                          |
|                         |   |    |   | or |                          |
|                         |   |    |   | i  |                          |
|                         |   |    |   | nd |                          |
|                         |   |    |   | iv |                          |
|                         |   |    |   | id |                          |
|                         |   |    |   | ua |                          |
|                         |   |    |   | ls |                          |
|                         |   |    |   | w  |                          |
|                         |   |    |   | ho |                          |
|                         |   |    |   | we |                          |
|                         |   |    |   | re |                          |
|                         |   |    |   | en |                          |
|                         |   |    |   | ro |                          |
|                         |   |    |   | ll |                          |
|                         |   |    |   | ed |                          |
|                         |   |    |   | th |                          |
|                         |   |    |   | is |                          |
|                         |   |    |   | y  |                          |
|                         |   |    |   | ea |                          |
|                         |   |    |   | r: |                          |
|                         |   |    |   | ** |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_15\_\_\_ Total      |   |    |   | Ge |                          |
| number of subjects to   |   |    |   | nd |                          |
| date                    |   |    |   | er |                          |
|                         |   |    |   | d  |                          |
|                         |   |    |   | is |                          |
|                         |   |    |   | tr |                          |
|                         |   |    |   | ib |                          |
|                         |   |    |   | ut |                          |
|                         |   |    |   | io |                          |
|                         |   |    |   | n: |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_\_0\_\_ Declined    |   |    |   | \  |                          |
| enrollment this past    |   |    |   | _\ |                          |
| year                    |   |    |   | _7 |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | %  |                          |
|                         |   |    |   | Fe |                          |
|                         |   |    |   | ma |                          |
|                         |   |    |   | le |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_0\_\_ Withdrawn     |   |    |   | \_ |                          |
| from project this past  |   |    |   | \_ |                          |
| year                    |   |    |   | 93 |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | %  |                          |
|                         |   |    |   | Ma |                          |
|                         |   |    |   | le |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Race/Ethnicity        |   |    |   |    |                          |
| Distribution of         |   |    |   |    |                          |
| enrolled subjects for   |   |    |   |    |                          |
| Domestic Studies:** (If |   |    |   |    |                          |
| an international study, |   |    |   |    |                          |
| provide race/ethnicity  |   |    |   |    |                          |
| of subjects by          |   |    |   |    |                          |
| estimated percentages): |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| \% American Indian or   |   |    | [ |    |                          |
| Alaskan Native          |   |    | 6 |    |                          |
|                         |   |    | 0 |    |                          |
|                         |   |    | ] |    |                          |
|                         |   |    | { |    |                          |
|                         |   |    | . |    |                          |
|                         |   |    | u |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | d |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | r |    |                          |
|                         |   |    | l |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | } |    |                          |
|                         |   |    | % |    |                          |
|                         |   |    | H |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | s |    |                          |
|                         |   |    | p |    |                          |
|                         |   |    | a |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | c |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| \% Asian or Pacific     |   |    | [ |    |                          |
| Islander                |   |    | 2 |    |                          |
|                         |   |    | 0 |    |                          |
|                         |   |    | ] |    |                          |
|                         |   |    | { |    |                          |
|                         |   |    | . |    |                          |
|                         |   |    | u |    |                          |
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|                         |   |    | r |    |                          |
|                         |   |    | l |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | } |    |                          |
|                         |   |    | % |    |                          |
|                         |   |    | W |    |                          |
|                         |   |    | h |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | t |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | , |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | t |    |                          |
|                         |   |    | o |    |                          |
|                         |   |    | f |    |                          |
|                         |   |    | H |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | s |    |                          |
|                         |   |    | p |    |                          |
|                         |   |    | a |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | c |    |                          |
|                         |   |    | O |    |                          |
|                         |   |    | r |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | g |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | n |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| [20]{.underline} %      |   |    |   |    |                          |
| Black or African        |   |    |   |    |                          |
| American, not of        |   |    |   |    |                          |
| Hispanic Origin         |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **3.** **Funding        |   |    |   |    |                          |
| Mechanisms &            |   |    |   |    |                          |
| Collaborating           |   |    |   |    |                          |
| Institutions**          |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| See attached listings   |   |    |   |    |                          |
| of sites, assurance     |   |    |   |    |                          |
| numbers and contract    |   |    |   |    |                          |
| numbers; 5 sites (#14,  |   |    |   |    |                          |
| 17, 20, 27, 63) shown   |   |    |   |    |                          |
| in boldface type are    |   |    |   |    |                          |
| those which enrolled    |   |    |   |    |                          |
| patients in Study 23C   |   |    |   |    |                          |
| (2588).                 |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **4. Summary of         |   |    |   |    |                          |
| research activities to  |   |    |   |    |                          |
| date -- briefly         |   |    |   |    |                          |
| summarize study         |   |    |   |    |                          |
| progress and            |   |    |   |    |                          |
| preliminary findings.** |   |    |   |    |                          |
| (Use additional sheets  |   |    |   |    |                          |
| as necessary): Study    |   |    |   |    |                          |
| began in November 1999. |   |    |   |    |                          |
| Enrollment continued    |   |    |   |    |                          |
| through October 2002,   |   |    |   |    |                          |
| with enrollment of      |   |    |   |    |                          |
| ^15^th patient. All     |   |    |   |    |                          |
| study activities with   |   |    |   |    |                          |
| patients have           |   |    |   |    |                          |
| concluded, and analysis |   |    |   |    |                          |
| is underway. Testing of |   |    |   |    |                          |
| samples has largely     |   |    |   |    |                          |
| concluded, and protocol |   |    |   |    |                          |
| team is drafting a      |   |    |   |    |                          |
| manuscript.             |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **5. Summary of study   |   |    |   |    |                          |
| modifications reviewed  |   |    |   |    |                          |
| & approved this past    |   |    |   |    |                          |
| year.** (Use additional |   |    |   |    |                          |
| sheets as               |   |    |   |    |                          |
| necessary): xx None     |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **6. Summary of any new |   |    |   |    |                          |
| literature, findings,   |   |    |   |    |                          |
| or other relevant       |   |    |   |    |                          |
| information.** (Use     |   |    |   |    |                          |
| additional sheets as    |   |    |   |    |                          |
| necessary): xx None     |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **7. Summary of         |   |    |   |    |                          |
| unanticipated problems  |   |    |   |    |                          |
| affecting study         |   |    |   |    |                          |
| progress to date.**     |   |    |   |    |                          |
| (Use additional sheets  |   |    |   |    |                          |
| as necessary):  Parent  |   |    |   |    |                          |
| study 23 (# 2174)       |   |    |   |    |                          |
| closed to enrollment in |   |    |   |    |                          |
| March 2002. This PK     |   |    |   |    |                          |
| substudy closed in      |   |    |   |    |                          |
| October 2002, after     |   |    |   |    |                          |
| enrollment of the       |   |    |   |    |                          |
| ^15^th patient.         |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+

+-----------------------------------+---------+---+-----------------------+
| **8. Summary of                   |         |   |                       |
| [anticipated]{.underline} adverse |         |   |                       |
| events (AAE).** Description of    |         |   |                       |
| AAE, including date of event,     |         |   |                       |
| date reported to investigator, &  |         |   |                       |
| outcome (CDC 0.1257 form not      |         |   |                       |
| required unless requested by the  |         |   |                       |
| IRB. Use additional sheets as     |         |   |                       |
| necessary):                       |         |   |                       |
|                                   |         |   |                       |
| xx None                           |         |   |                       |
+-----------------------------------+---------+---+-----------------------+
| **9. Consent documents** (attach  |         |   |                       |
| a copy of each current            |         |   |                       |
| consent/assent form, oral script, |         |   |                       |
| and/or consent letter):           |         |   |                       |
|                                   |         |   |                       |
| xx None (subject enrollment is    |         |   |                       |
| complete)                         |         |   |                       |
+-----------------------------------+---------+---+-----------------------+
| 10. **Summary of remaining        |         |   |                       |
|     activities** (use additional  |         |   |                       |
|     sheets as                     |         |   |                       |
|     necessary): Completion of     |         |   |                       |
|     specimen analyses,            |         |   |                       |
|     finalization of data analysis |         |   |                       |
|     and drafting of manuscript    |         |   |                       |
|     reporting study findings. In  |         |   |                       |
|     general, the study            |         |   |                       |
|     demonstrated that the dose    |         |   |                       |
|     adjustments proposed by the   |         |   |                       |
|     study protocol resulted in    |         |   |                       |
|     safe and effective levels of  |         |   |                       |
|     both rifabutin and efavirenz. |         |   |                       |
|                                   |         |   |                       |
+-----------------------------------+---------+---+-----------------------+
| **Triage Checklist Completed      |         | * |                       |
| by: AAV    **                     |         | * |                       |
|                                   |         | D |                       |
|                                   |         | a |                       |
|                                   |         | t |                       |
|                                   |         | e |                       |
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|                                   |         | p |                       |
|                                   |         | 2 |                       |
|                                   |         | 0 |                       |
|                                   |         | , |                       |
|                                   |         | 2 |                       |
|                                   |         | 0 |                       |
|                                   |         | 0 |                       |
|                                   |         | 4 |                       |
|                                   |         |   |                       |
|                                   |         |   |                       |
|                                   |         |   |                       |
|                                   |         |   |                       |
|                                   |         | * |                       |
|                                   |         | * |                       |
+-----------------------------------+---------+---+-----------------------+
| **Required Items**                |         | * |                       |
|                                   |         | * |                       |
|                                   |         | Y |                       |
|                                   |         | E |                       |
|                                   |         | S |                       |
|                                   |         | o |                       |
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|                                   |         | / |                       |
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|                                   |         | * |                       |
|                                   |         | * |                       |
+-----------------------------------+---------+---+-----------------------+
| 1\. Scientific Ethics             |         | x |                       |
| Verification (SEV)#s for          |         | x |                       |
| [all]{.underline} CDC             |         | Y |                       |
| investigators?                    |         | E |                       |
|                                   |         | S |                       |
+-----------------------------------+---------+---+-----------------------+
| 2\. Current status of protocol    |         | x |                       |
| checked (still enrolling, data    |         | x |                       |
| analysis, etc.)?                  |         | Y |                       |
|                                   |         | E |                       |
|                                   |         | S |                       |
+-----------------------------------+---------+---+-----------------------+
| 3\. History of participant        |         | x |                       |
| enrollment provided?              |         | x |                       |
|                                   |         | Y |                       |
|                                   |         | E |                       |
|                                   |         | S |                       |
+-----------------------------------+---------+---+-----------------------+
| 4\. Summary of activities to date |         | x |                       |
| provided?                         |         | x |                       |
|                                   |         | Y |                       |
|                                   |         | E |                       |
|                                   |         | S |                       |
+-----------------------------------+---------+---+-----------------------+
| 5\. Summary of remaining          |         | x |                       |
| activities provided?              |         | x |                       |
|                                   |         | Y |                       |
|                                   |         | E |                       |
|                                   |         | S |                       |
+-----------------------------------+---------+---+-----------------------+
| 6\. Consent form included         |         | X |                       |
| (required if still enrolling      |         | x |                       |
| subjects)?                        |         | N |                       |
|                                   |         | o |                       |
|                                   |         | t |                       |
|                                   |         | R |                       |
|                                   |         | e |                       |
|                                   |         | q |                       |
|                                   |         | u |                       |
|                                   |         | i |                       |
|                                   |         | r |                       |
|                                   |         | e |                       |
|                                   |         | d |                       |
+-----------------------------------+---------+---+-----------------------+
| 7\. If any changes to Conflict of |         |   |                       |
| Interest (COI) 0.1258 form,       |         | x |                       |
| please complete new form.         |         | x |                       |
|                                   |         | N |                       |
|                                   |         | / |                       |
|                                   |         | A |                       |
+-----------------------------------+---------+---+-----------------------+
| **Approvals/Signatures**          | **Date  |   | **Remarks**           |
|                                   |      ** |   |                       |
+-----------------------------------+---------+---+-----------------------+
| As principal CDC investigator, I  |         |   |                       |
| hereby accept responsibility for  |         |   |                       |
| conducting this CDC-sponsored     |         |   |                       |
| research project in an ethical    |         |   |                       |
| manner, consistent with the       |         |   |                       |
| policies and procedures contained |         |   |                       |
| in CDC\'s \"Procedures for        |         |   |                       |
| Protection of Human Research      |         |   |                       |
| Participants\" and to abide by    |         |   |                       |
| the principles outlined in 45 CFR |         |   |                       |
| 46, \"Protection of Human         |         |   |                       |
| Subjects.\"                       |         |   |                       |
+-----------------------------------+---------+---+-----------------------+
| Investigator: Andrew Vernon       | 09/     |   |                       |
|                                   | 20/2004 |   |                       |
+-----------------------------------+---------+---+-----------------------+
| Branch Chief: \--SAME\--          | 9/      |   |                       |
|                                   | 20/2004 |   |                       |
+-----------------------------------+---------+---+-----------------------+
| Division Director:                |         |   |                       |
+-----------------------------------+---------+---+-----------------------+
| CIO HS Contact:                   |         |   |                       |
+-----------------------------------+---------+---+-----------------------+

List of Participating TBTC Sites and OPRR Assurance Numbers#

**SITE NUMBER, NAME & LOCATION OPRR Assurance No. Federal Wide Assurance
No. Contract Number (if FWA exists at site) or VA site/subsite\***

12 New York University School of Medicine, NY NY \-\-\-\-- FWA #00004952
200-1999-00105

13 New Jersey School of Medicine, Newark NJ \-\-\-\-- FWA #00000036
200-1999-00097

**14 Johns Hopkins University, Baltimore MD M-1011 \-\-\-\--
200-1999-00104**

15 Emory Univ. School of Medicine M-1426 \-\-\-\-- 200-2002-00676

16 Univ. of Calif. at San Diego \-\-\-\-- FWA #00004495 200-2002-00677

**17 Los Angeles County/USC Med. Center, LA CA M-1372 \-\-\-\--
200-1999-00096**

**20 Univ.of N.TX Health Science Center, Ft Worth TX M-1536 \-\-\-\--
200-1999-00095**

21 University of Manitoba, Manitoba CANADA \-\-\-\-- FWA #00002049
200-1999-00107

22 Denver Department of Public Health, Denver CO \-\-\-\-- FWA #00004689
200-1999-00136

23 Boston University Med. Center, Boston MA \-\-\-\-- FWA #00000301
200-1999-00099

24 Columbia University, New York NY \-\-\-\-- FWA #00002636
200-1999-00103

New York City Dept. of Health M-1541 \-\-\-\-- \-\-\--

25 Montreal Chest Institute, Montreal CANADA \-\-\-\-- FWA #00000840
200-1999-00106

26 Seattle-King County HD, Seattle WA \-\-\-- FWA #00000028
200-1999-00100

**27 University of British Columbia, Vancouver CANADA \-\-\-\-- FWA
#00000668 200-1999-00102**

28 Univ. of California at San Francisco, San Francisco CA \-\-\-\-- FWA
#00000068 200-1999-00098

29 Rio de Janiero Brazil, Inst Infec Dis San Sebastain, Hosp Munc.
Infantil Darcy Vargas FWA#00003052 FWA#00003053 200-2002-00675

Hosp Universitario Clemention Fraga Filho, FWA #00000377 200-2002-00675

30 Case Western Reserve Univ, School of Med, Cleveland OH \-\-\-\-- FWA
#00004428 \-\-\-\--

Makere Medical School, Kampala Uganda \-\-\-\-- FWA #00001293 Pending

31 Barcelona \-\-\-\-- Pending Pending

**SITE NUMBER, NAME & LOCATION OPRR Assurance No. Federal Wide Assurance
No. Contract Number (if FWA exists at site) or VA site/subsite\***

40 South Texas subsites (Texas Dept. of Health) \-\-\-\-- FWA #00000694
VA\*

53 Washington DC VAMC, Washington DC \-\-\-\-- FWA #00002475 VA\*

Maryland Dept Hlth & Mental Hyg \-\-\-\-- FWA #00001222 (Montgomery
County) \-\-\-\--

54 Durham, NC VAMC \-\-\-\-- FWA #000001600 VA\*

Duke University, Durham NC M-1106 \-\-\-\-- \-\-\-\--

58 Little Rock VAMC, Little Rock AR \-\-\-\-- FWA #00001119 VA\*

> Univ of AR for Med. Sciences \-\-\-\-- FWA #00001119 \-\-\-\--
>
> Arkansas Dept of Health \-\-\-\-- FWA #00002961 VA\*

59 Hines VAMC, Hines IL \-\-\-\-- FWA #00001478 VA\*

61 Chicago-Lakeside VAMC, Chicago IL \-\-\-\-- FWA #00001565 VA\*

62 Houston VAMC, Houston TX \-\-\-\-- FWA #00001471 VA\*

> Baylor Medical School \-\-\-\-- FWA #00000286 \-\-\-\--

**63 Audie L. Murphy Memorial VAMC, San Antonio \-\-\-\-- FWA #00001220
VA\***

Texas Department of Health \-\-\-\-- FWA #00000694 \-\-\-\--

66 Harlem Hospital, Columbia University, New York NY \-\-\-\-- FWA
#00000119 VA\*

68 Carolinas Medical Center, Charlotte, NC \-\-\-\-- FWA #00000387 VA\*

70 Nashville VAMC, Nashville TN (Vanderbilt Univ) \-\-\-\-- FWA
#00003772 VA\*

> Metro Health Dept., Nashville TN \-\-\-- FWA#00000474 \-\-\-\--

Westat Inc., Rockville MD M-1531 \-\-\-\-- Not a site

#Indented entries are sub-sites or affiliated universities \*Funded
through VA side of consortium, via Memorandum of Agreement

> **Appendix A: Patient Informed Consent** **Study 23C**
>
> INTRODUCTION/PURPOSE
>
> This research study is sponsored by the (name of the institution) and
> the U.S. Centers for Disease Control and Prevention (CDC). You have
> HIV infection and you are being treated for tuberculosis (TB) with a
> rifabutin based regimen. You may also be a study patient in TB Trials
> Consortium (TBTC) Study 23. (Study 23 is called "Treatment of
> HIV-Related Tuberculosis Using a Rifabutin-Based Regimen"). Your HIV
> doctor has recommended that you begin medicines that include efavirenz
> for your HIV infection.
>
> You are now being asked to be a part of a study to measure the amount
> of the TB medicines and the HIV medicine, efavirenz, in your blood.
> This will help us to better understand how the efavirenz affects the
> TB medicines. It will also help us to understand how the TB medicines
> affect the efavirenz. About 20 persons will be enrolled in this study.
>
> PROCEDURES
>
> If you are not participating in TBTC Study 23, we will take about 2
> tablespoons of blood to test your liver, kidney and blood counts. We
> will also ask you a few questions about past health history and other
> health problems. Answering these questions will take about 15-30
> minutes. You do not have to answer these questions if you do not want
> to.
>
> You will be admitted to either our Clinical Research Center (CRC) or
> outpatient clinic at two different times. The first admission will be
> after you complete your first two months of treatment for your TB and
> after you have received at least four doses of your twice a week
> treatment with rifabutin. On your first day, you will come to the CRC
> or outpatient clinic and have breakfast. (1) You will have your blood
> drawn. You will be asked about any medicine that you have taken since
> the night before. (2) You will receive your dose of TB medicines. (3)
> You will have your blood drawn six more times in the next 24 hours.
> These blood drawings will take place at 1, 3, 5, 7, 9 and 21 hours
> after the dose of your TB medications. At each blood draw, about two
> teaspoons (10cc) of your blood will be drawn.
>
> Your second admission will be two to six weeks after you have started
> taking your HIV medicines, including efavirenz. You will need to bring
> all of your medicines to the CRC or outpatient clinic. We will give
> you your usual doses of your own medicine. On the first day of your
> second admission, (1) you will have your blood drawn when you arrive.
> You will be asked about any medicine that you have taken since the
> night before. (2) You will receive your usual dose of efavirenz with
> breakfast after your blood is drawn and then again 24 hours later. (3)
> You will be given your usual dose of TB medicines three hours after
> you have taken the morning dose of efavirenz. (4) You will have your
> blood drawn seven more times in the next 24 hours. These blood
> drawings will take place at 2, 4, 6, 8, 10, 12 and 24 hours after
> receiving the morning dose of efavirenz. At each blood draw, about one
> tablespoon (15 cc) of your blood will be drawn. The tubes that contain
> your blood will be labeled with a study number only. No name will be
> included. The blood will be sent to outside laboratories for testing.
>
> During each admission, you may also have two or three tablespoons (30
> -- 45 cc) of blood drawn for other testing including a CD4 count, a
> blood count, an HIV viral load, and tests for hepatitis B and C, and
> for your liver. If we have recent results of some of these tests, we
> won't repeat the tests. The HIV viral load test will also be sent to
> an outside lab. It will be labeled with your study number only. The
> HIV viral load test will not be done until much later, so the results
> of this test will not be helpful to you or your doctor. The total
> amount of blood taken for both admissions will be about 21 tablespoons
> (315 cc or a little less than 1 ½ cups).
>
> During both admissions to the Clinical Research Center or outpatient
> clinic your medical records will be reviewed. You will also be asked
> if you are taking any other medicines, if you have had any problems
> such as stomach upset or diarrhea. You will be asked other questions
> about your medical history and your HIV infection.
>
> About sixty days after your second admission, you will be called on
> the phone or seen in person. We will ask you questions about your
> health since the last admission. We will also review your records.
>
> RISKS
>
> The risks of blood drawing include pain and bruising from the needle
> stick and dizziness. Rarely, infection occurs where the needle enters
> the vein.
>
> Information for women: You should not take part in this study if you
> are now pregnant or if you plan to become pregnant before completing
> your treatment for TB. If you are a woman who can become pregnant, you
> will be asked to have a pregnancy test before starting the study.
> Rifabutin can interfere with the effectiveness of pills, shots, and
> implants used for birth control. While taking rifabutin, you should
> not rely on these methods to prevent pregnancy. Instead, you should
> use condoms, diaphragms, sponges/cervical caps or an intrauterine
> device (IUD). (Only condoms can prevent the transmission of sexually
> transmitted diseases including HIV infection). If you do become
> pregnant, you should notify your doctor immediately, so that your
> treatment can be changed.
>
> BENEFITS
>
> There is no direct benefit to you if you take part in this research
> study. You may help us better understand treatment of TB and HIV.
>
> ALTERNATIVE TREATMENT
>
> You do not have to be a part of this study if you do not want to. It
> is not standard treatment to measure the amount of TB or HIV medicines
> in the blood. If you are not a part of the study, it will not affect
> your regular medical care. If you do not choose to be a part of this
> study, your TB or HIV treatment will not be changed in any way.
>
> PRIVATE RECORDS
>
> For this study, information about you , your TB treatment, and your
> HIV treatment will be collected. This information will be sent to the
> CDC and an outside lab. No information sent to CDC or to the outside
> lab will identify you by name. No published report of the results of
> this study will identify you by name. This study involves medicines
> regulated by the Food and Drug Administration (FDA). Therefore, the
> FDA may review your records. Study monitors from the CDC or the VA may
> also review your study records. All information from your medical
> records will be kept private as much as possible.
>
> COST OF THE STUDY AND COMPENSATION
>
> You will not have to pay for any tests that are part of this study.
> You will be paid \$6.00 an hour for being a part of this study. This
> study will take about 28 hours for each admission for a total of 56
> hours. *(Individual site methods for compensation should be listed
> here.)* This will cover for your time and inconvenience. You will also
> receive \$30.00 (*individualize*) for your travel to the Clinical
> Research Center or the outpatient clinic for each occasion that you
> are admitted.
>
> IN CASE OF INJURY
>
> If you are injured because you are taking part in this study, and the
> injury requires medical attention, neither CDC nor (name of the
> institution) normally give free medical care or compensation for the
> injury. You (or your insurer, Medicare, or Medicaid) might have to pay
> for the medical treatment yourself. However, you are not giving up any
> of your rights by being in this study. Medical treatment will be
> offered to you at (name of the institution).
>
> RIGHT TO REFUSE OR WITHDRAW
>
> This study is voluntary. If you choose to take part in this study, you
> may change your mind and withdraw at any time without affecting your
> regular medical care. Your TB treatment and your HIV treatment will
> remain unchanged if you quit the study. If new information is found
> that might change your being willing to stay in the study, we will
> tell you.
>
> CONTACT PERSONS
>
> You may contact Dr. \_\_\_\_\_\_\_at (Phone #) if you have any
> questions about this study. If you have any questions about your
> rights as a research subject, you may contact (Human Subjects Contact,
> Phone #). If you feel you have been injured because of this study,
> please call \_\_\_\_\_\_\_\_ (name of local contact) at
> \_\_\_\_\_\_\_\_\_\_\_\_ (local telephone number).
>
> This consent form will be placed in your medical record. You will be
> given a copy of this consent form to keep.
>
> CONSENT
>
> My signature shows that I understand the information in this consent.
> I have had my questions answered to my satisfaction. I agree to
> volunteer to be in this study.
>
> Signature of Participant:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
> \_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Signature of Person Obtaining Consent:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date: \_\_\_\_\_\_\_
>
> Signature of Investigator:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Thank you for taking part in our study. CDC would like to store any
> remaining samples of blood for possible future testing related to TB
> disease or TB drugs. If any of these future tests produce important
> information about your health, this information will be provided to
> you and your physician. If CDC wishes to perform any other future
> testing, we will contact you and ask for your permission. You will
> have the right in the future, to have any of your stored specimens
> removed and destroyed. This can be done by calling Dr. (local
> PI)\_\_\_\_\_\_ at \_\_\_\_\_\_\_.
>
> CHECK ONE:
>
> Yes, I agree to storage of samples No, I do not agree to storage of
> samples
>
> Signature of Participant:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
> Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_