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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Atazanavir Sulfate; Efavirenz; Emtricitabine; Lopinavir; Ritonavir; Tenofovir

Criteria

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.