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

HIV Infections Clinical Trial

Official title:

A Phase II, 48-Week, Open-Label Study Designed to Evaluate the Safety, Tolerability, and Efficacy of a Simplified Dosing Regimen of Viracept (Nelfinavir Mesylate) 1250 Mg BID, Crixivan (Indinavir Sulfate) 1200mg q12h, and Sustiva (Efavirenz; DMP-266) 600 Mg q24h for the Treatment of HIV-1 Infection in Non-Nucleoside Reverse Transcriptase Inhibitor and Protease Inhibitor Naive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002235
• Other study ID #: 259G
• Secondary ID: ICC 602
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Nelfinavir mesylate

• Efavirenz

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Univ of Colorado / Health Science Ctr	Denver	Colorado
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Brown Univ School of Medicine	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	Agouron Pharmaceuticals

Country where clinical trial is conducted

United States,