Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if the multidrug combination of zidovudine (ZDV), lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and effective treatment for HIV-infected patients and if there is a reduction of active HIV in blood and other tissues.

HIV infection is a life-changing illness and new HIV treatments must be tested. This study will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues and if it is safe and well tolerated. Doctors also want to know if the multidrug combination is able to decrease viral activity over a long time period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Glaxo Wellcome
• Treatments: Abacavir; Amprenavir; Lamivudine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 18 years old.

• Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV infection.

• Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for chronically infected patients only).

• Are able to follow study requirements.

• Agree to practice reliable forms of birth control such as barrier or surgical methods, starting 1 month prior to entry and while enrolled in the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have had prior anti-HIV treatment (for recently infected patients only).

• Have a history of blood-clotting problems.

• Have ever received treatment with protease inhibitors or 3TC.

• Are at high risk for developing an infection in the heart.

• Are critically ill.

• Are mentally disabled, a prisoner, or confined in an institution.

• Are breast-feeding or pregnant.

• Have gastrointestinal problems that might interfere with drug absorption or are unable to take medicines by mouth.

• Need regular blood transfusions.

• Have had an unexplained fever higher than 38.5 C for more than 14 days within 30 days of enrollment.

• Have an opportunistic (AIDS-related) infection that requires treatment (treatment must be completed 30 days before the start of the study).

• Are taking certain medications that may interfere with the study.