Once-daily Antiretroviral Therapy in HIV-1 Infected Patients With CD4+ Cell Counts Below 100 Cells/Mcl (ADVANZ-3)

Juan A. Arnaiz

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: tenofovir + emtricitabine + lopinavir-ritonavir; Drug: tenofovir + emtricitabine + atazanavir-ritonavir; Drug: tenofovir + emtricitabine + efavirenz

Study type: Interventional

Funder types: Other

Identifiers

NCT00532168

EudraCT: 2006-006268-42

ADVANZ-3

FIS grant: EC07/90642

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

1

Experimental group

Description:

tenofovir plus emtricitabine plus efavirenz

Treatment:

Drug: tenofovir + emtricitabine + efavirenz

2

Experimental group

Description:

tenofovir plus emtricitabine plus lopinavir-ritonavir

Treatment:

Drug: tenofovir + emtricitabine + lopinavir-ritonavir

3

Experimental group

Description:

tenofovir plus emtricitabine plus atazanavir-ritonavir

Treatment:

Drug: tenofovir + emtricitabine + atazanavir-ritonavir