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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
Hospital Clinic
Barcelona, Catalonia, Spain
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned
Time frame: 48 weeks
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