A Study of the Long-Term Outcomes of HIV-Positive Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00000932
- Brief Summary
The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all.
Anti-HIV treatment has been successful in slowing disease progression in many patients. However, there are still questions regarding the best way to use anti-HIV drugs. This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment.
- Detailed Description
Highly active antiretroviral therapy (HAART) often results in short-term benefits for people with HIV in terms of reduced plasma viral levels and increased CD4 cell counts. When used at an early stage of HIV disease, however, the clinical benefit of HAART is uncertain. Many questions still remain regarding the optimal use of antiretroviral therapies, such as the timing of initial antiretroviral therapy and the composition of the best combination regimen to use initially or after virologic failure. Randomized trials of different starting antiretroviral regimens (e.g., FIRST \[CPCRA 058\]), different regimens after initial virologic failure (e.g., PIP \[CPCRA 057\]), and different management strategies for HIV infection (e.g., bis-POM \[CPCRA 039\], NvR \[CPCRA 042\], GART \[CPCRA 046\], and IL-2 VL/Dose \[CPCRA 059\] are being conducted by the CPCRA. \[AS PER AMENDMENT 2/28/01: The MDR-HIV (CPCRA 064) protocol is now included as an example of a different management strategy for HIV infection, whereas the bis-POM (CPCRA 039) protocol is no longer included.\] This study provides a mechanism for long-term monitoring of patients enrolled in these trials as well as antiretroviral-naive patients who are either starting treatment or electing to defer treatment.
Patients are divided into 3 groups. Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study (see Purpose for CPCRA trials which qualify). Group B consists of patients previously enrolled in but not currently being followed in a qualifying study. Group C consists of antiretroviral-naive patients not enrolling in a qualifying study (i.e., patients starting treatment outside the FIRST study or patients deferring treatment). Patients in Group A undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled. Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 months. Patients are followed for at least 5 years. \[AS PER AMENDMENT 2/28/01: Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST (CPCRA 058) protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved, HIV-related research. Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release (every 4 months) of their medical records from their new health care provider to the CPCRA.\]
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3669
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical disease progression or death Throughout study
- Secondary Outcome Measures
Name Time Method Survival Throughout study Selected metabolic, hepatic, and cardiovascular conditions Throughout study Changes in viral load Throughout study Changes in CD4 count Throughout study Changes in HIV treatment methods Throughout study
Related Research Topics
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Trial Locations
- Locations (91)
Dr. M. Estes Med. Practice CRS
🇺🇸Mill Valley, California, United States
Dr. Robert Scott Med. Practice CRS
🇺🇸Oakland, California, United States
East Bay AIDS Ctr. CRS
🇺🇸Oakland, California, United States
Dr. Shawn Hassler Med. Practice CRS
🇺🇸San Francisco, California, United States
Positive Health Program Clinic (San Francisco Gen. Hosp.) CRS
🇺🇸San Francisco, California, United States
Dr. Virginia Cafaro Med. Practice CRS
🇺🇸San Francisco, California, United States
Dr. William Owen Med. Practice CRS
🇺🇸San Francisco, California, United States
Castro-Mission Health Ctr. CRS
🇺🇸San Francisco, California, United States
Dr. Martin Mass Med. Practice CRS
🇺🇸San Francisco, California, United States
St. Mary's Med. Ctr. of San Francisco CRS
🇺🇸San Francisco, California, United States
Scroll for more (81 remaining)Dr. M. Estes Med. Practice CRS🇺🇸Mill Valley, California, United States