A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
NCT ID: NCT00001069
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1100 participants
OBSERVATIONAL
Brief Summary
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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
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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 \[900 patients\]).
Conditions
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Study Design
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NATURAL_HISTORY
Eligibility Criteria
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Inclusion Criteria
* 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
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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Thompson M
Role: STUDY_CHAIR
Perez G
Role: STUDY_CHAIR
Locations
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Community Consortium of San Francisco
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Baltimore Trials
Baltimore, Maryland, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners Research
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
The Research and Education Group
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Countries
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References
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Doepel LK. Volunteers needed for study of HIV viral load test. NIAID AIDS Agenda. 1995 Dec:3.
James JS. Viral load: new "strategy" trial in 15 U.S. cities. AIDS Treat News. 1995 Oct 20;(no 233):1-3.
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)
Other Identifiers
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CPCRA 036
Identifier Type: -
Identifier Source: org_study_id