Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients

HIV Infections Clinical Trial

Official title:

A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents in Treatment-Naive HIV-Infected Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00004998
• Other study ID #: 286B
• Secondary ID: AG1549-503
• Status: Suspended
• Phase: Phase 2
• First received: March 21, 2000
• Last updated: June 23, 2005
• Start date: November 1999

Study information

• Verified date: March 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine/Zidovudine

• Capravirine

• Nelfinavir mesylate

Locations

Country	Name	City	State
Dominican Republic	Immunity Care and Research Inc	Santo Domingo
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Beth Israel Deaconess Med Ctr	Boston	Massachusetts
United States	Clin Research of West Florida	Clearwater	Florida
United States	Community Health Care	Fort Lauderdale	Florida
United States	Catholic Med Ctr	Jamaica	New York
United States	South Shore Hosp	Miami	Florida
United States	Liberty Medical	New York	New York
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	Infectious Diseases Associates	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Agouron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Dominican Republic,