A Study to See If Taking One or Two Extra Drugs Can Lower HIV Levels in Patients Who Have Failed Their Anti-HIV Drug Treatment

• Status: Completed
• Trial end date: 2002-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if adding 1 or 2 drugs to the anti-HIV therapy of patients whose HIV levels increased while taking their anti-HIV drugs can lower viral load (amount of HIV in the blood) and keep it low up to Week 24. (This study has been changed. Previously, only patients whose levels increased on their first round of anti-HIV drugs were being studied.) Anti-HIV drug treatments that contain a combination of 3 or more drugs can lower HIV levels, raise CD4 cell counts, and improve survival. Unfortunately, many patients "fail" their anti-HIV drug treatment when their HIV levels go above 500 copies/ml. Usually the next step is to switch the patient to different anti-HIV drugs. Doctors would like to see whether adding 1 or 2 different drugs to the "failed" treatment also can lower HIV levels. Adding 1 or 2 drugs might be better than switching all of the drugs since patients who take many different drugs can develop drug-resistant HIV. (This study has been changed. Previously, only patients taking protease inhibitors (PI) whose levels increased on their first round of anti-HIV drugs were being studied.)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Amprenavir; Ritonavir

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.

• Are taking 3 or more anti-HIV drugs for at least 24 weeks. (This study has been changed. Previously, only patients taking their first round of anti-HIV drugs, which included a PI, were being studied.)

• Had a viral load below 500 copies/ml while on their anti-HIV drugs, and then had an increase in viral load to between 500 and 10,000 copies/ml. (This study has been changed. Previously, only patients whose levels increased on their first round of anti-HIV drugs were being studied.)

• Have a CD4 cell count of 100 cells/mm3 or more.

• Are age 13 or older (consent of a parent or legal guardian is required if under 18).

• Agree to use 2 methods of birth control during the study and for 60 days after. (This study has changed the birth control requirements.)

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are currently being treated for a serious infection or other serious medical illness.

• Have had certain illnesses in the past.

• Have a fever within 7 days of study entry.

• Have already taken all of the study drugs for more than 4 weeks.

• Are unable to take any of the study drugs.

• Have certain types of cancer.

• Received certain vaccines within 21 days of study entry.

• Have received certain medications.

• Are pregnant or breast-feeding.

• Patients will not be eligible for Group A if they:

• Have a history of hypersensitivity reaction to abacavir.