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.
Name: tenofovir + emtricitabine + efavirenz
Description: tenofovir + emtricitabine + efavirenz, approved dose, oral route, QDType: Drug1
Name: tenofovir + emtricitabine + lopinavir-ritonavir
Description: tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved doseType: Drug2
Name: tenofovir + emtricitabine + atazanavir-ritonavir
Description: tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QDType: Drug3
Allocation: Randomized
Parallel Assignment
There are 6 SNPs
- 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. --- M184V --- --- K65R --- --- L33I --- --- V82A --- --- I84V ---
- 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. --- M184V --- --- K65R ---
- 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. --- M184V --- --- K65R --- --- L33I ---
- 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. --- M184V --- --- K65R --- --- L33I --- --- V82A --- --- I84V --- --- L90M ---
- 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. --- M184V ---
- 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. --- M184V --- --- K65R --- --- L33I --- --- V82A ---