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Report for Clinical Trial NCT00532168

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT00532168 HIV Infections
MeSH: HIV Infections

3 Interventions

Name: tenofovir + emtricitabine + efavirenz

Description: tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD

Type: Drug

1

Name: tenofovir + emtricitabine + lopinavir-ritonavir

Description: tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose

Type: Drug

2

Name: tenofovir + emtricitabine + atazanavir-ritonavir

Description: tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

Type: Drug

3


Primary Outcomes

Measure: Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned

Time: 48 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 6 SNPs

SNPs


1 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 --- --- L33I --- --- V82A --- --- I84V ---


2 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 ---


3 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 ---


4 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 --- --- K65R --- --- L33I --- --- V82A --- --- I84V --- --- L90M ---


5 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 ---


6 V82A

- 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 ---



HPO Nodes