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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.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00532168
First received: September 18, 2007
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00532168

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

No publications provided

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov 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
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
advanced HIV-infected patients
late presenters
antiretroviral therapy
immune reconstitution
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atazanavir
Efavirenz
Emtricitabine
Lopinavir
Ritonavir
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014