Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00004999
- Lead Sponsor
- Agouron Pharmaceuticals
- Brief Summary
The purpose of this study is to look at the effectiveness of giving a new anti-HIV drug (AG1549) plus Viracept (nelfinavir) plus Combivir (a tablet containing zidovudine plus lamivudine) to HIV-infected patients who are not taking anti-HIV drugs.
- Detailed Description
\[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] Patients are randomized to receive Viracept plus Combivir plus either AG1549 or placebo. Patients remain on their assigned therapy for 48 weeks with one post-therapy follow-up visit. Blood samples are taken regularly to quantify plasma HIV-1 RNA, CD4 and CD8 counts, and peripheral blood mononuclear cells (PBMC). Physical exams, safety assessments, and other tests are also done throughout the study. A blood sample is taken at baseline (pre-dose) for a pharmacokinetics assessment. On Day 8 and at the end of Weeks 4, 8, 16, 24, 36, and 48, pharmacokinetic sampling is done prior to dosing and between 2 to 4 hours post-dose.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 350
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Arizona Clinical Research Ctr Inc
🇺🇸Tucson, Arizona, United States
Univ of Southern California
🇺🇸Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
ViRx Inc
🇺🇸Palm Springs, California, United States
Research & Treatment at the California Pacific Med Ctr
🇺🇸San Francisco, California, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
IDC Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Community Health Care
🇺🇸Fort Lauderdale, Florida, United States
Univ of Florida
🇺🇸Jacksonville, Florida, United States
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