Clinical trial NCT00001069: A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
Official title: A Randomized Study of the Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Decision Making
Physician's Practice Patterns
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 1100
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY

Brief summary: PRIMARY: To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy: decision making based on current clinical practice alone (i.e., initiating or changing therapy based on CD4 count decline and/or clinical progression) versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice.

SECONDARY: To evaluate toxicity, biological markers, and patient management in the two arms.

Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.

Detailed description: Although changing therapies is a common strategy in the treatment of HIV disease, guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated. The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy. However, uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms.

Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs. decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with \<= 300 CD4+ cells/mm3. All patients in the RNA arm as well as a subset (n = 183) of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months. The results of these quantitations will be blinded until the end of the study. CD4 counts will be obtained at least every 4 months if the previous count was \> 20 cells/mm3. The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians' current clinical practices. Medications, clinical status, and changes in antiretroviral therapy will be recorded for all patients in the study. Patients are stratified by CD4+ cell count (\<100 cells/mm3 \[200 patients\] vs. 100-300 cells/mm3 \[900 patients\]).

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 count \<= 300 cells/mm3.
* NO stage 2 or worse AIDS dementia complex.
* Life expectancy of at least 6 months.
* Reasonably good health.
* age \>= 13yrs.
* signed informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Disorders or conditions that may prevent adequate compliance with study requirements.

Patients with the following prior conditions are excluded:

* Stage 2 \>= AIDS dementia complex.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Community Consortium of San Francisco
state: California
city: Denver
country: United States
facility: Denver CPCRA / Denver Public Hlth
state: Colorado
city: Washington
country: United States
facility: Veterans Administration Med Ctr / Regional AIDS Program
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Trials
state: Maryland
city: Detroit
country: United States
facility: Comprehensive AIDS Alliance of Detroit
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Camden
country: United States
facility: Southern New Jersey AIDS Cln Trials / Dept of Med
state: New Jersey
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Albuquerque
country: United States
facility: Partners Research
state: New Mexico
city: New York
country: United States
facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr
state: New York
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
Study officials:
name: Thompson M
role: STUDY_CHAIR
name: Perez G
role: STUDY_CHAIR
References:
citation: Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec:3.
citation: James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3.
citation: Raghavan S, Grant LB, Barisch G, Thompson M, Williams B, Matoe N, el-Sadr WM. Change in log10 HIV RNA and protease inhibitor use associated with weight change in HIV+ men in a national clinical trial. Int Conf AIDS. 1998;12:556 (abstract no 32180)