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

• Status: Completed
• Trial end date: 2001-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Agouron Pharmaceuticals
• Treatments: Capravirine; Nelfinavir; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• 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.

Exclusion Criteria

Patients will not be eligible for this study if they:

• 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.