A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

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

Summary

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: HIV Protease Inhibitors; Lopinavir; Nevirapine; Protease Inhibitors; Reverse Transcriptase Inhibitors; Ritonavir

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 12 years old.

• Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.

• Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.

• Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.

• Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have an active illness.

• Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.

• Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).

• Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.

• Have received treatment with a PI other than their current PI.

• Are receiving chemotherapy for cancer.

• Are pregnant or breast-feeding.