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

NCT ID: NCT00002239

Last Updated: 2005-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-05-31

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.

Conditions

HIV Infections

Keywords

HIV-1; Dose-Response Relationship, Drug; Drug Therapy, Combination; VX 478; Anti-HIV Agents; pentafuside; abacavir; efavirenz

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Enfuvirtide

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Abacavir sulfate

Intervention Type: DRUG

Amprenavir

Intervention Type: DRUG

Efavirenz

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trimeris

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Locations

Pacific Oaks Research

Beverly Hills, California, United States

UCLA Care Ctr

Los Angeles, California, United States

ViRx Inc

Palm Springs, California, United States

Donald Northfelt

Palm Springs, California, United States

UCSD

San Diego, California, United States

ViRx Inc

San Francisco, California, United States

Quest Clinical Research

San Francisco, California, United States

Dupont Circle Physicians Group

Washington D.C., 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

Johns Hopkins Hosp

Baltimore, Maryland, United States

Washington Univ School of Medicine

St Louis, Missouri, United States

New York Univ Med Ctr

New York, New York, United States

Trimeris Inc

Durham, North Carolina, United States

Associates of Med and Mental Health

Tulsa, Oklahoma, United States

Pennsylvania Oncology and Hematology Associates

Philadelphia, Pennsylvania, United States

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Univ of Pittsburgh

Pittsburgh, Pennsylvania, United States

Central Texas Clinical Research

Austin, Texas, United States

Countries

United States

Other Identifiers

295B

Identifier Type: -

Identifier Source: secondary_id

T20-206

Identifier Type: -

Identifier Source: org_study_id