A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
Stopped early
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00001069
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 1100
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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