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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002239

Run by

Hoffmann-La Roche

People needed

68

Starts

1999-05-01

Last updated by the study team

2005-11-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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