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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532168

Acronym

ADVANZ-3

Enrollment

108

Registered

2007-09-20

Start date

2007-09-30

Completion date

2012-12-31

Last updated

2013-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

advanced HIV-infected patients, late presenters, antiretroviral therapy, immune reconstitution, Treatment Naive

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.

Interventions

DRUGtenofovir + emtricitabine + efavirenz

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

DRUGtenofovir + emtricitabine + lopinavir-ritonavir

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

DRUGtenofovir + emtricitabine + atazanavir-ritonavir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026