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

NCT00532168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2013-02-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Juan A. Arnaiz

    lead OTHER

Principal Investigators

  • Jose M Miró, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00532168 on ClinicalTrials.gov