Changing to Nonprotease Inhibitor Treatment to Improve Side Effects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn whether changing from a type of anti-HIV drug called a protease inhibitor (PI) to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood.

PIs have been effective at keeping HIV viral load (amount of HIV in the blood) down. However, some people who take PIs have higher than normal levels of fats and/or sugars in the blood. Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects. This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; Dideoxynucleosides; Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Nevirapine; Zidovudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV infected.

• Are on their first combination of stable anti-HIV drugs (have not changed drugs for at least 6 months, except for reasons other than failing treatment or short interruptions of less than 7 days).

• Have 2 measurements of viral load (amount of HIV in the blood) during the 6 months before entering the study that are below 400 copies/ml by RT-PCR test or below 500 copies/ml by branched DNA test, measured at least 8 weeks apart.

• Have a viral load below 50 copies/ml within 30 days prior to entry.

• Have a CD4 cell count of 200 copies/ml or higher within 60 days of study entry.

• Are receiving medications and/or medications at certain doses that might interfere with the study.

• Are at least 13 years old and have signed consent of parent or guardian if under 18 years of age.

• Have a negative pregnancy test within 14 days of study entry, if a woman able to have children.

• Agree to use a barrier method of birth control, men and women, while receiving study drugs and for 3 months afterwards.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are receiving high doses of testosterone. Low doses are allowed if received for 60 or more days before entering the study with no plans to change the dose during the first 24 weeks of the study.

• Have had treatment with any nonnucleoside reverse transcriptase inhibitor (NNRTI).

• Have had treatment with ABC.

• Are allergic to study drugs or any ingredient in them.

• Are pregnant or breast-feeding.

• Have used any HIV vaccine or drugs affecting the immune system within 30 days prior to entering the study.

• Have had systemic treatment for cancer within 30 days of entering the study.

• Have had systemic treatment with certain other drugs that may interfere with the study within 14 days of entering the study.

• Have a serious illness that required systemic treatment or a hospital stay unless treatment was completed at least 14 days prior to entering the study, or are on stable treatment, in the doctor's opinion, for at least 14 days prior to entering the study.

• Abuse drugs or alcohol.

• Have or suspect they have acute hepatitis within 30 days of entering the study.