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

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

Sponsors

Lead Sponsor: Hoffmann-La Roche

Collaborator: Trimeris

Source 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.

Overall Status Completed
Start Date May 1999
Phase Phase 2
Study Type Interventional
Enrollment 68
Condition
Intervention

Intervention Type: Drug

Intervention Name: Enfuvirtide

Intervention Type: Drug

Intervention Name: Ritonavir

Intervention Type: Drug

Intervention Name: Abacavir sulfate

Intervention Type: Drug

Intervention Name: Amprenavir

Intervention Type: Drug

Intervention Name: Efavirenz

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Pacific Oaks Research | Beverly Hills, California, 90211, United States
UCLA Care Ctr | Los Angeles, California, 90095, United States
ViRx Inc | Palm Springs, California, 92262, United States
Donald Northfelt | Palm Springs, California, 92270, United States
UCSD | San Diego, California, 92103, United States
ViRx Inc | San Francisco, California, 94109, United States
Quest Clinical Research | San Francisco, California, 94115, United States
Dupont Circle Physicians Group | Washington, District of Columbia, 200091104, United States
IDC Research Initiative | Altamonte Springs, Florida, 32701, United States
Gary Richmond MD | Fort Lauderdale, Florida, 33316, United States
AIDS Research Consortium of Atlanta | Atlanta, Georgia, 30308, United States
Johns Hopkins Hosp | Baltimore, Maryland, 21287, United States
Washington Univ School of Medicine | St. Louis, Missouri, 63110, United States
New York Univ Med Ctr | New York, New York, 10016, United States
Trimeris Inc | Durham, North Carolina, 27707, United States
Associates of Med and Mental Health | Tulsa, Oklahoma, 74114, United States
Pennsylvania Oncology and Hematology Associates | Philadelphia, Pennsylvania, 19106, United States
Philadelphia FIGHT | Philadelphia, Pennsylvania, 19107, United States
Univ of Pittsburgh | Pittsburgh, Pennsylvania, 15261, United States
Central Texas Clinical Research | Austin, Texas, 78705, United States
Location Countries

United States

Verification Date

November 2005

Keywords
Condition Browse
Study Design Info

Primary Purpose: Treatment

Source: ClinicalTrials.gov