Overview

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.