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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

tenofovir plus emtricitabine plus efavirenz

Group Type EXPERIMENTAL

tenofovir + emtricitabine + efavirenz

Intervention Type DRUG

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

2

tenofovir plus emtricitabine plus lopinavir-ritonavir

Group Type EXPERIMENTAL

tenofovir + emtricitabine + lopinavir-ritonavir

Intervention Type DRUG

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

3

tenofovir plus emtricitabine plus atazanavir-ritonavir

Group Type EXPERIMENTAL

tenofovir + emtricitabine + atazanavir-ritonavir

Intervention Type DRUG

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

Interventions

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tenofovir + emtricitabine + efavirenz

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

Intervention Type DRUG

tenofovir + emtricitabine + lopinavir-ritonavir

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

Intervention Type DRUG

tenofovir + emtricitabine + atazanavir-ritonavir

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No