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OpenTrials
Completed

NCT Number: NCT00532168

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, Catalonia, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tenofovir + emtricitabine + efavirenz

Drug

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

tenofovir + emtricitabine + lopinavir-ritonavir

Drug

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

tenofovir + emtricitabine + atazanavir-ritonavir

Drug

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

Primary outcomes

  1. Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Juan A. Arnaiz

Other

Registry information

Official study title

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

Acronym: ADVANZ-3

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 20, 2007
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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