Trials / Suspended
SuspendedNCT00004999
Effectiveness of a New Anti-HIV Drug (AG1549) Plus Viracept (Nelfinavir) Plus Combivir (Zidovudine/Lamivudine) in HIV-Infected Patients
A Randomized, Double-Blind, Placebo-Controlled Study of AG1549 in Combination With Viracept (Nelfinavir Mesylate) and Combivir (Zidovudine + Lamivudine) in Treatment-Naive HIV-Infected Patients
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 350 (planned)
- Sponsor
- Agouron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lamivudine/Zidovudine | |
| DRUG | Capravirine | |
| DRUG | Nelfinavir mesylate |
Timeline
- Start date
- 1999-08-01
- First posted
- 2001-08-31
- Last updated
- 2005-06-24
Locations
53 sites across 4 countries: United States, Canada, Dominican Republic, Puerto Rico
Source: ClinicalTrials.gov record NCT00004999. Inclusion in this directory is not an endorsement.