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

HIV Infections Clinical Trial

Official title:

A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002239
• Other study ID #: T20-206
• Secondary ID: 295B
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: November 14, 2005
• Start date: May 1999

Study information

• Verified date: November 2005
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.

• Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.

• Are at least 18 years old.

• Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).

• Have an opportunistic (HIV-related) infection.

• Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.

• Have had diarrhea lasting at least 15 days within 30 days prior to screening.

• Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).

• Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.

• Are allergic to any of the study medications.

• Have a tumor other than certain skin or cervical cancers.

• Are on chemotherapy that cannot be discontinued during the study.

• Are taking an investigational drug within 30 days prior to screening.

• Have ever received an HIV vaccine.

• Are taking certain medications.

• Abuse drugs or alcohol.

• Have hemophilia or another blood clotting disorder.

• Have had an organ transplant.

• Are pregnant or breast-feeding.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide

• Ritonavir

• Abacavir sulfate

• Amprenavir

• Efavirenz

Locations

Country	Name	City	State
United States	IDC Research Initiative	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Central Texas Clinical Research	Austin	Texas
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Pacific Oaks Research	Beverly Hills	California
United States	Trimeris Inc	Durham	North Carolina
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	UCLA Care Ctr	Los Angeles	California
United States	New York Univ Med Ctr	New York	New York
United States	Donald Northfelt	Palm Springs	California
United States	ViRx Inc	Palm Springs	California
United States	Pennsylvania Oncology and Hematology Associates	Philadelphia	Pennsylvania
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Univ of Pittsburgh	Pittsburgh	Pennsylvania
United States	UCSD	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	ViRx Inc	San Francisco	California
United States	Washington Univ School of Medicine	St. Louis	Missouri
United States	Associates of Med and Mental Health	Tulsa	Oklahoma
United States	Dupont Circle Physicians Group	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Trimeris

Country where clinical trial is conducted

United States,