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

Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.

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.

Inclusion Criteria:

• Chronic HIV-1 infection
• Age 18 or more
• Antiretroviral-naive
• Baseline CD4+ count <100 cels/mcL.
• No mutations of drug resistance at baseline (M184V/I, K65R, resistance to efavirenz or 2 or more PRAMs (L33I/F/V, V82A/F/L/T, I84V, L90M)
• Written informed consent

Exclusion Criteria:

• Hypersensibility to study drugs.
• Pregnancy or breastfeeding
• Active OI requiring admission
• Active lymphoma or malignancy (Kaposi sarcoma included)
• Cl creatinine below 30 ml/min.
• Liver failure
• Treatment with nephrotoxic drugs, immunomodulators, interleukine-2, systemic steroids or investigational products.