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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: tenofovir + emtricitabine + lopinavir-ritonavir; Drug: tenofovir + emtricitabine + efavirenz; Drug: tenofovir + emtricitabine + atazanavir-ritonavir

• Registration Number: NCT00532168
• Lead Sponsor: Juan A. Arnaiz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	tenofovir + emtricitabine + lopinavir-ritonavir	tenofovir plus emtricitabine plus lopinavir-ritonavir
1	tenofovir + emtricitabine + efavirenz	tenofovir plus emtricitabine plus efavirenz
3	tenofovir + emtricitabine + atazanavir-ritonavir	tenofovir plus emtricitabine plus atazanavir-ritonavir

Primary Outcome Measures

Name	Time	Method
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned	48 weeks

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Catalonia, Spain