Title
ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past
A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects
Phase
Phase 2Lead Sponsor
ViRxStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
HIV InfectionsStudy Participants
NoneThe purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).
All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml. Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry. Have received more than 1 PI for at least 12 weeks each at some time in the past. Exclusion Criteria Patients will not be eligible for this study if they: Have had any active opportunistic (AIDS-related) infections within the past 30 days. Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz. Have received certain medications. Are pregnant or breast-feeding. Abuse alcohol or drugs.