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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532168
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : February 22, 2013
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: tenofovir + emtricitabine + efavirenz Drug: tenofovir + emtricitabine + lopinavir-ritonavir Drug: tenofovir + emtricitabine + atazanavir-ritonavir Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : September 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 1
tenofovir plus emtricitabine plus efavirenz
Drug: tenofovir + emtricitabine + efavirenz
tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD

Experimental: 2
tenofovir plus emtricitabine plus lopinavir-ritonavir
Drug: tenofovir + emtricitabine + lopinavir-ritonavir
tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose

Experimental: 3
tenofovir plus emtricitabine plus atazanavir-ritonavir
Drug: tenofovir + emtricitabine + atazanavir-ritonavir
tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD

Primary Outcome Measures :
  1. Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00532168

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Hospital Clinic
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
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Study Chair: Jose M Miró, MD Hospital Clinic of Barcelona
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT00532168    
Other Study ID Numbers: ADVANZ-3
EudraCT: 2006-006268-42
FIS grant: EC07/90642
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
advanced HIV-infected patients
late presenters
antiretroviral therapy
immune reconstitution
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Atazanavir Sulfate
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers