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

Study Overview
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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.

Official Title
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Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl. A Prospective, Randomized, Multicentre, Open Clinical Study.

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: tenofovir + emtricitabine + efavirenz
* Drug: tenofovir + emtricitabine + lopinavir-ritonavir
* Drug: tenofovir + emtricitabine + atazanavir-ritonavir


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>tenofovir plus emtricitabine plus efavirenz | Drug: tenofovir + emtricitabine + efavirenz<br>* tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD<br>|
| Experimental: 2<br>tenofovir plus emtricitabine plus lopinavir-ritonavir | Drug: tenofovir + emtricitabine + lopinavir-ritonavir<br>* tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose<br>|
| Experimental: 3<br>tenofovir plus emtricitabine plus atazanavir-ritonavir | Drug: tenofovir + emtricitabine + atazanavir-ritonavir<br>* tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, Treatment Naive