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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002239
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2005-11
• Last Update Submitted: 2005-11-14
• Last Update Posted: 2005-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (19)

Pacific Oaks Research; 🇺🇸 Beverly Hills, California, United States

UCLA Care Ctr; 🇺🇸 Los Angeles, California, United States

ViRx Inc; 🇺🇸 San Francisco, California, United States

Donald Northfelt; 🇺🇸 Palm Springs, California, United States

UCSD; 🇺🇸 San Diego, California, United States

Quest Clinical Research; 🇺🇸 San Francisco, California, United States

Dupont Circle Physicians Group; 🇺🇸 Washington, District of Columbia, United States

IDC Research Initiative; 🇺🇸 Altamonte Springs, Florida, United States

Gary Richmond MD; 🇺🇸 Fort Lauderdale, Florida, United States

AIDS Research Consortium of Atlanta; 🇺🇸 Atlanta, Georgia, United States

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