NCT00532168

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	tenofovir + emtricitabine + efavirenz	tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
DRUG	tenofovir + emtricitabine + lopinavir-ritonavir	tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
DRUG	tenofovir + emtricitabine + atazanavir-ritonavir	tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-09-20
• Last updated: 2013-02-22

Locations

1 site across 1 country: Spain