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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.)

Key facts

Study ID

NCT00006152

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

42

Expected to finish

2002-08-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Southern California / LA County USC Med Ctr — Los Angeles, California, United States
• Univ of California, San Diego — San Diego, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• The CORE Ctr — Chicago, Illinois, United States
• Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
• St Louis Regional Hosp / St Louis Regional Med Ctr — St Louis, Missouri, United States
• Beth Israel Med Ctr — New York, New York, United States
• Univ of North Carolina — Chapel Hill, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Univ of Texas Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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