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

NCT ID: NCT00002235

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL

Brief 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).

Detailed Description

Patients receive a treatment regimen consisting of nelfinavir, indinavir, and efavirenz for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA levels and lymphocyte subsets and for development of adverse events and toxicities. After Week 48, patients with documented virologic response are eligible to continue receiving study treatments and to attend scheduled follow-up visits. Patients who experience virologic failure are discontinued from the study.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Indinavir sulfate

Intervention Type: DRUG

Nelfinavir mesylate

Intervention Type: DRUG

Efavirenz

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agouron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Locations

Pacific Oaks Med Group

Beverly Hills, California, United States

Univ of Colorado / Health Science Ctr

Denver, Colorado, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

Brown Univ School of Medicine

Providence, Rhode Island, United States

Hampton Roads Med Specialists

Hampton, Virginia, United States

Countries

United States

Other Identifiers

ICC 602

Identifier Type: -

Identifier Source: secondary_id

259G

Identifier Type: -

Identifier Source: org_study_id