Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00004998
- Lead Sponsor
- Agouron Pharmaceuticals
- Brief Summary
The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV drugs are safe and effective in 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 one of two doses of AG1549 plus Viracept (nelfinavir) plus Combivir (zidovudine/lamivudine). Patients remain on their assigned therapy for 48 weeks, with a follow-up visit at 28 to 35 days after the last dose of study medication. Blood samples are taken regularly to quantify HIV-1 RNA, CD4 and CD8 counts, peripheral blood mononuclear cells (PBMC), AG1549, Viracept, and M8 plasma concentrations. Physical exams, safety assessments, and other tests are also done throughout the study. On Day 8 and at the end of Week 48, pharmacokinetic samples are collected at 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose. At the end of Weeks 4, 8, 16, 24, and 36, pharmacokinetic samples are taken prior to dosing and between 2 to 4 hours post-dose.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 30
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 (10)
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Anderson Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Community Health Care
🇺🇸Fort Lauderdale, Florida, United States
South Shore Hosp
🇺🇸Miami, Florida, United States
Catholic Med Ctr
🇺🇸Jamaica, New York, United States
Immunity Care and Research Inc
🇩🇴Santo Domingo, Dominican Republic
Liberty Medical
🇺🇸New York, New York, United States
Clin Research of West Florida
🇺🇸Clearwater, Florida, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States