Summary

for people ages 18 years and up (full criteria)
at UCSFUCLA
study started

Description

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.

Official Title

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

Details

[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.

Keywords

HIV InfectionsDrug Therapy, CombinationZidovudineHIV Protease InhibitorsLamivudineDisease ProgressionReverse Transcriptase InhibitorsAnti-HIV AgentsViral LoadNelfinavirCombivirLamivudine, zidovudine drug combinationCapravirineLamivudine/ZidovudineNelfinavir mesylate

Eligibility

You can join if…

Open to people ages 18 years and up

Patients may be eligible if they:

  • Are HIV-positive.
  • Are at least 18 years old.
  • Have a CD4 cell count of more than 50 cells/mm3.
  • Have an HIV level of more than 5000 copies/ml.

You CAN'T join if...

Patients will not be eligible if they:

  • Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry.
  • Have taken an experimental drug within 28 days of study entry.

Locations

  • Highland Gen Hosp / San Francisco Gen Hosp
    OaklandCalifornia946021018United States
  • Harbor - UCLA Med Ctr
    TorranceCalifornia90502United States
  • Research & Treatment at the California Pacific Med Ctr
    San FranciscoCalifornia94114United States

Details

Status
currently not accepting new patients, but might later
Start Date
Sponsor
Agouron Pharmaceuticals
ID
NCT00004999
Phase
Phase 2
Study Type
Interventional
Last Updated