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

This study has been completed.
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona Identifier:
First received: September 18, 2007
Last updated: February 21, 2013
Last verified: February 2013
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 Intervention Phase
HIV Infections Drug: tenofovir + emtricitabine + efavirenz Drug: tenofovir + emtricitabine + lopinavir-ritonavir Drug: tenofovir + emtricitabine + atazanavir-ritonavir Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

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

Enrollment: 108
Study Start Date: September 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00532168

Hospital Clinic
Barcelona, Catalonia, Spain, 08036
Sponsors and Collaborators
Juan A. Arnaiz
Study Chair: Jose M Miró, MD Hospital Clinic of Barcelona
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT00532168     History of Changes
Other Study ID Numbers: ADVANZ-3
EudraCT: 2006-006268-42
FIS grant: EC07/90642
Study First Received: September 18, 2007
Last Updated: February 21, 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:
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 processed this record on September 21, 2017