A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Trimeris
• Treatments: Abacavir; Amprenavir; Dideoxynucleosides; Efavirenz; Enfuvirtide; Ritonavir

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.

• Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.

• Are at least 18 years old.

• Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).

• Have an opportunistic (HIV-related) infection.

• Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.

• Have had diarrhea lasting at least 15 days within 30 days prior to screening.

• Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).

• Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.

• Are allergic to any of the study medications.

• Have a tumor other than certain skin or cervical cancers.

• Are on chemotherapy that cannot be discontinued during the study.

• Are taking an investigational drug within 30 days prior to screening.

• Have ever received an HIV vaccine.

• Are taking certain medications.

• Abuse drugs or alcohol.

• Have hemophilia or another blood clotting disorder.

• Have had an organ transplant.

• Are pregnant or breast-feeding.