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A Study of Capravirine Plus VIRACEPT Plus Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Patients Who Failed Previous Anti-HIV Treatments

Sponsored by Agouron Pharmaceuticals

About this trial

Last updated 20 years ago

Study ID

286E

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 24 years ago

What is this trial about?

The purpose of this study is to see if the addition of capravirine to VIRACEPT (nelfinavir mesylate) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is an effective combination drug therapy for HIV patients who have failed a nonnucleoside reverse transcriptase inhibitor (NNRTI) therapy.

What are the participation requirements?

Yes

Inclusion Criteria

- Are HIV positive.

- Are at least 18 years old.

- Are currently taking an NNRTI and at least 1 NRTI for at least 28 days and failing that therapy. (Patients who began an NRTI therapy without an NNRTI and then added an NNRTI may also enroll.)

- Are on the current NNRTI plus NRTI therapy at the time of the screening visit.

- Have a CD4 count greater than 50/mm3 and viral load greater than 2,000 copies/ml at the screening visit.

- Have adequate blood, kidney, and liver functions.

- Agree to use a barrier method of birth control while on the study.

- Agree to use additional methods of birth control if less than 2 years postmenopausal.

No

Exclusion Criteria

- Are using or have received other investigative drugs within 28 days of receiving the first dose of study drug.

- Are using or have received any medications or radiation treatments that interfere with the study drug within 28 days of receiving the first dose of study drug.

- Have had prior treatment with capravirine or any protease inhibitors.

- Are pregnant or breast-feeding.

- Have an active infection or serious medical condition.

- Have a mental, social, or addictive disorder that may interfere with study treatment.

Locations

Location

Status