Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) to one that includes three nucleoside reverse transcriptase inhibitors (NRTIs) plus an NNRTI. NNRTIs, NRTIs, and protease inhibitors are all types of anti-HIV drugs that block the virus in some way.

This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI. CD4 cells are cells of the immune system that fight infection. This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Abacavir; HIV Protease Inhibitors; Lamivudine; Lopinavir; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir; Stavudine

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are 18 years of age or older.

• Are HIV-positive.

• Have a CD4 count of 500 cells/mm3 or less.

• Have a viral load greater than 5,000 and less than 100,000 copies/ml.

• Are willing to use barrier methods of birth control (such as condoms) during the study and for 12 weeks after stopping treatment.

• Will most likely respond well to nevirapine. This is determined by the results of a test.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have ever taken any anti-HIV drugs. (Seven days or less of treatment will be allowed if it was received more than 30 days before study entry.)

• Have pancreatitis (an inflamed pancreas) or hepatitis within 2 weeks of study entry.

• Are pregnant or breast-feeding.

• Actively abuse drugs or alcohol which their doctor feels would interfere with the ability to fulfill study requirements.

• Have taken any medications within 14 days of study entry that would interfere with the study drugs.

• Are receiving or need to receive chemotherapy.