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

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Suspended

CT.gov ID

NCT00004998

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine/Zidovudine Drug: Capravirine Drug: Nelfinavir mesylate	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clin Research of West Florida	Clearwater	Florida	United States	33765
2	Community Health Care	Fort Lauderdale	Florida	United States	33306
3	South Shore Hosp	Miami	Florida	United States	33139
4	Infectious Diseases Associates	Sarasota	Florida	United States	34239
5	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
6	Beth Israel Deaconess Med Ctr	Boston	Massachusetts	United States	02215
7	Catholic Med Ctr	Jamaica	New York	United States	11432
8	Liberty Medical	New York	New York	United States	10014
9	Anderson Clinical Research	Pittsburgh	Pennsylvania	United States	15221
10	Immunity Care and Research Inc	Santo Domingo		Dominican Republic