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Summary

Eligibility
for people ages 18 years and up
Location
at Oakland, California and other locations
Dates
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 Infections Drug Therapy, Combination Zidovudine HIV Protease Inhibitors Lamivudine Disease Progression Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Nelfinavir Combivir Lamivudine, zidovudine drug combination

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

  • Research & Treatment at the California Pacific Med Ctr
    San Francisco, California, 94114, United States
  • Univ of Southern California
    Los Angeles, California, 90033, United States
  • Harbor - UCLA Med Ctr
    Torrance, California, 90502, United States
  • ViRx Inc
    Palm Springs, California, 92262, United 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
March 2001