**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 |    |                          |
|                         |   |    | 1 |    |                          |
|                         |   |    | 7 |    |                          |
|                         |   |    | 3 |    |                          |
|                         |   |    | * |    |                          |
|                         |   |    | * |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **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:**     |   |    |   |    |                          |
| **Pharmacokinetics of   |   |    |   |    |                          |
| Intermittent Isoniazid  |   |    |   |    |                          |
| and Rifabutin in USPHS  |   |    |   |    |                          |
| Study 23: Treatment of  |   |    |   |    |                          |
| HIV-Related             |   |    |   |    |                          |
| Tuberculosis Using a    |   |    |   |    |                          |
| Rifabutin-Based         |   |    |   |    |                          |
| Regimen**               |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Proposed Project      |   | ** |   |    | **End:**  02/06          |
| Dates**                 |   | Be |   |    |                          |
|                         |   | gi |   |    |                          |
|                         |   | n: |   |    |                          |
|                         |   | ** |   |    |                          |
|                         |   | 0  |   |    |                          |
|                         |   | 2/ |   |    |                          |
|                         |   | 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: |                          |
|                         |   |    |   | ** |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_120\_ Total number  |   |    |   | Ge |                          |
| of subjects to date     |   |    |   | nd |                          |
|                         |   |    |   | er |                          |
|                         |   |    |   | d  |                          |
|                         |   |    |   | is |                          |
|                         |   |    |   | tr |                          |
|                         |   |    |   | ib |                          |
|                         |   |    |   | ut |                          |
|                         |   |    |   | io |                          |
|                         |   |    |   | n: |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_\_0\_\_ Declined    |   |    |   | \_ |                          |
| enrollment this past    |   |    |   | \_ |                          |
| year                    |   |    |   | 21 |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | %  |                          |
|                         |   |    |   | Fe |                          |
|                         |   |    |   | ma |                          |
|                         |   |    |   | le |                          |
+-------------------------+---+----+---+----+--------------------------+
| \_\_0\_\_ Withdrawn     |   |    |   | \_ |                          |
| from project this past  |   |    |   | \_ |                          |
| year                    |   |    |   | 79 |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | \_ |                          |
|                         |   |    |   | %  |                          |
|                         |   |    |   | Ma |                          |
|                         |   |    |   | le |                          |
+-------------------------+---+----+---+----+--------------------------+
| **Race/Ethnicity        |   |    |   |    |                          |
| Distribution of         |   |    |   |    |                          |
| enrolled subjects for   |   |    |   |    |                          |
| Domestic Studies:** (If |   |    |   |    |                          |
| an international study, |   |    |   |    |                          |
| provide race/ethnicity  |   |    |   |    |                          |
| of subjects by          |   |    |   |    |                          |
| estimated percentages): |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| [0]{.underline} %       |   |    | [ |    |                          |
| American Indian or      |   |    | 3 |    |                          |
| Alaskan Native          |   |    | 4 |    |                          |
|                         |   |    | ] |    |                          |
|                         |   |    | { |    |                          |
|                         |   |    | . |    |                          |
|                         |   |    | u |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | d |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | r |    |                          |
|                         |   |    | l |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | } |    |                          |
|                         |   |    | % |    |                          |
|                         |   |    | H |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | s |    |                          |
|                         |   |    | p |    |                          |
|                         |   |    | a |    |                          |
|                         |   |    | n |    |                          |
|                         |   |    | i |    |                          |
|                         |   |    | c |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| [3]{.underline} % Asian |   |    | [ |    |                          |
| or Pacific Islander     |   |    | 8 |    |                          |
|                         |   |    | ] |    |                          |
|                         |   |    | { |    |                          |
|                         |   |    | . |    |                          |
|                         |   |    | u |    |                          |
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|                         |   |    | d |    |                          |
|                         |   |    | e |    |                          |
|                         |   |    | 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 |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| [55]{.underline} %      |   |    |   |    |                          |
| Black or African        |   |    |   |    |                          |
| American, not of Hisp.  |   |    |   |    |                          |
| Origin                  |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **3.** **Funding        |   |    |   |    |                          |
| Mechanisms &            |   |    |   |    |                          |
| Collaborating           |   |    |   |    |                          |
| Institutions**          |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| See attached listings   |   |    |   |    |                          |
| of sites, assurance     |   |    |   |    |                          |
| numbers and contract    |   |    |   |    |                          |
| numbers; 17 sites (#12, |   |    |   |    |                          |
| 13, 17, 20, 21, 22, 27, |   |    |   |    |                          |
| 28, 53, 54, 59, 62, 63, |   |    |   |    |                          |
| 66, 68, 70) enrolled    |   |    |   |    |                          |
| patients in Study 23A   |   |    |   |    |                          |
| (2173).                 |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **4. Summary of         |   |    |   |    |                          |
| research activities to  |   |    |   |    |                          |
| date -- briefly         |   |    |   |    |                          |
| summarize study         |   |    |   |    |                          |
| progress and            |   |    |   |    |                          |
| preliminary findings.** |   |    |   |    |                          |
| (Use additional sheets  |   |    |   |    |                          |
| as necessary): Study    |   |    |   |    |                          |
| began in Feb. 1999.     |   |    |   |    |                          |
| Enrollment continued    |   |    |   |    |                          |
| through September 2002. |   |    |   |    |                          |
| All study activities    |   |    |   |    |                          |
| with patients have      |   |    |   |    |                          |
| concluded, and analysis |   |    |   |    |                          |
| is underway. Testing of |   |    |   |    |                          |
| samples has largely     |   |    |   |    |                          |
| concluded, and protocol |   |    |   |    |                          |
| team is finalizing a    |   |    |   |    |                          |
| manuscript.             |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **5. Summary of study   |   |    |   |    |                          |
| modifications reviewed  |   |    |   |    |                          |
| & approved this past    |   |    |   |    |                          |
| year.** (Use additional |   |    |   |    |                          |
| sheets as               |   |    |   |    |                          |
| necessary): xx None     |   |    |   |    |                          |
| (Protocol was amended   |   |    |   |    |                          |
| in spring 2002 to allow |   |    |   |    |                          |
| enrollment of new       |   |    |   |    |                          |
| relapse patients after  |   |    |   |    |                          |
| completion of therapy,  |   |    |   |    |                          |
| in association with     |   |    |   |    |                          |
| recognition of problem  |   |    |   |    |                          |
| with acquired rifamycin |   |    |   |    |                          |
| resistant relapse).     |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+
| **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.             |   |    |   |    |                          |
+-------------------------+---+----+---+----+--------------------------+

+--------------------------------+--------+---+--------------------------+
| **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. Copy of draft        |        |   |                          |
| manuscript is attached.        |        |   |                          |
+--------------------------------+--------+---+--------------------------+
| **Triage Checklist Completed   |        | * |                          |
| by: AAV    **                  |        | * |                          |
|                                |        | D |                          |
|                                |        | a |                          |
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|                                |        | 0 |                          |
|                                |        | , |                          |
|                                |        | 2 |                          |
|                                |        | 0 |                          |
|                                |        | 0 |                          |
|                                |        | 4 |                          |
|                                |        |   |                          |
|                                |        |   |                          |
|                                |        |   |                          |
|                                |        |   |                          |
|                                |        | * |                          |
|                                |        | * |                          |
+--------------------------------+--------+---+--------------------------+
| **Required Items**             |        | * |                          |
|                                |        | * |                          |
|                                |        | Y |                          |
|                                |        | E |                          |
|                                |        | S |                          |
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|                                |        | / |                          |
|                                |        | A |                          |
|                                |        | ) |                          |
|                                |        | * |                          |
|                                |        | * |                          |
+--------------------------------+--------+---+--------------------------+
| 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   |        | x |                          |
| date 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**       | *      |   | **Remarks**              |
|                                | *Date  |   |                          |
|                                |     ** |   |                          |
+--------------------------------+--------+---+--------------------------+
| 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     |   |                          |
|                                | /20/04 |   |                          |
+--------------------------------+--------+---+--------------------------+
| Branch Chief: \--Same\--       | 09     |   | **Approved**             |
|                                | /20/04 |   |                          |
+--------------------------------+--------+---+--------------------------+
| Division Director:             |        |   | **Approved**             |
+--------------------------------+--------+---+--------------------------+
| CIO HS Contact:                |        |   | **Approved**             |
+--------------------------------+--------+---+--------------------------+

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

> **Patient Informed Consent**

TBTC Study 23A: Isoniazid and Rifabutin Pharmacokinetics

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 are being treated **or have been treated** for tuberculosis (TB) as
part of **TBTC** Study 23. (Study 23 is called "Treatment of HIV-Related
Tuberculosis Using a Rifabutin-Based Regimen".) **Your study treatment
did not cure your TB, and you have gotten other medicines.** As part of
the study, you are **still** coming to the clinic for treatment
and**/or** study visits. We are now asking you to be part of a study to
measure the level of the TB medicines in your blood. This will help us
to understand **why the medicines don't work** well in some people.

PROCEDURE

We will ask you to spend about 6 hours in clinic on the first day and
about 1 hour in clinic on the second day. On the first day, (1) we will
draw your blood when you arrive to clinic. We will ask you about any
medicine that you took since the night before. We will also ask about
your food intake. (2) **You will get a dose of isoniazid and/or a dose
of rifabutin at the same dose you got during Study 23 when you were
getting your medicines twice a week.** (3) We will draw blood from you
five more times in the next 24 hours. These blood draws will take place
in the clinic at one, two, three, six, and twenty-four hours after the
dose of your TB medicines. At each blood draw, we will take about 1
tablespoon of your blood. The total amount of blood taken for the study
will be about 4 tablespoons (60 cc). 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 an outside lab for testing. (4) We will review
your medical record. We will also ask you about the way in which you
took your TB medicines. We will ask if you are taking any other
medicines. We will ask if you have had any problems such as stomach
upset or diarrhea. We will also ask you other questions about your
medical history and your HIV.

RISKS

**If you are not currently getting isoniazid or rifabutin, you will get
a copy of your signed Study 23 Consent Form. We will go over the
isoniazid and rifabutin risk sections with you.** The risks of blood
draws include pain and bruising from the needle stick and dizziness.
Rarely, infection occurs where the needle enters the vein.

ALTERNATIVES

You do not have to be a part of this study if you do not want to. It is
not standard treatment to measure blood levels of TB drugs. If you are
not a part of the study, you will not lose any benefits. You can still
be a part of the main study without having the drug levels measured. You
will still receive your care at this clinic.

BENEFITS

You will not get any direct benefit if you are a part of this project.
You may help to better cure TB disease for future patients.

COMPENSATION/COSTS

If you have a problem as a result of this study, you may require medical
attention. Neither CDC nor (name of the institution) has set aside money
to pay for treatment of the reaction. You might have to pay for the
medical treatment yourself. Medical treatment will be offered to you at
(name of the institution) .

You will be paid up to a total of \$66 for the first day and \$48 for
the second day, for being a part of this study. The study nurse or
coordinator at your site will tell you exactly how this payment will be
made. This will cover payment for your time and inconvenience. This will
also pay for your travel to the clinic.

CONFIDENTIALITY

For this project, information about you and your TB treatment will be
collected. This information will be sent to the CDC and an outside lab.
We will not send your name to CDC or to the outside lab. No written
report of the results of this study will have your name. This study
involves medicines that the Food and Drug Administration (FDA) checks.
Therefore, the FDA may look at your records. Study monitors from the CDC
or the VA may also look at your study records. Your medical records will
be kept confidential (secret) to the extent legally possible.

VOLUNTARY PARTICIPATION/WITHDRAWAL

If you do not choose to be a part of this study, your TB treatment will
not be changed in any way. If you choose to take part in this study, you
may change your mind and withdraw at any time, and your TB treatment
will not change.

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 (IRB Chairman, Phone #). If you feel
you have any injury from this study, please call \_\_\_\_\_\_\_\_ (name
of local contact) at \_\_\_\_\_\_\_\_\_\_\_\_ (local telephone number).

NEW FINDINGS

If we learn of new results , which could affect your treatment, we will
tell you If researchers learn important things about your health, we
will tell you or your doctor. Please write in here the name and address
of the person to whom information should be sent (if not yourself):

> Name:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

ENTITLEMENT OF CONSENT FORM TO PATIENT

You will be given a copy of this consent form to keep.

CONSENT

I, the undersigned, understand the consent form and have had my
questions answered to my satisfaction. I consent to volunteer to
participate in this study.

Signature of Participant:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_

Signature of Witness:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date:
\_\_\_\_\_\_\_\_\_\_\_\_\_

Signature of Investigator:
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Date:\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Thank you for being in our study. CDC would like to keep any blood that
is left over for possible future tests about TB disease or TB drugs. If
any of these new test results might be important to your health, we will
contact your doctor. If CDC wants to do any other future tests, we will
contact you to ask if it is okay. You always have the right to ask us to
remove and destroy your stored samples. 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:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Original to Principal Investigator, 1 copy to study participant