Overview

Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing three parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of three different combinations of antiretroviral therapy given once a day (QD): tenofovir plus emtricitabine plus either efavirenz, lopinavir-ritonavir or atazanavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
Phase:
Phase 4
Details
Lead Sponsor:
Juan A. Arnaiz
Treatments:
Atazanavir Sulfate
Efavirenz
Emtricitabine
Lopinavir
Ritonavir
Tenofovir