A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors

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

Summary

Indinavir is usually taken three times a day. The purpose of this study is to see if it is safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a day) and efavirenz (taken once a day).

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Collaborator: Agouron Pharmaceuticals
• Treatments: Efavirenz; HIV Protease Inhibitors; Indinavir; Nelfinavir; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Are at least 13 years old (consent of parent or guardian required if under 18).

• Have a viral load of at least 10,000 copies/ml within 30 days of study entry.

• Agree to use a barrier method of birth control, such as condoms, during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have hepatitis.

• Have any other serious medical condition besides HIV infection.

• Are allergic to indinavir, nelfinavir, or efavirenz.

• Have ever taken NNRTIs or protease inhibitors.

• Have had chemotherapy or radiation therapy within 30 days of study entry. (Local radiation therapy is allowed.)

• Have taken certain other medications that might affect your immune system such as interleukin-2, interferon, or a vaccine within 30 days of study entry.

• Are enrolled or plan to enroll in another anti-HIV drug study during this study.

• Are pregnant or breast-feeding.

• Abuse alcohol or drugs.