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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

September 18, 2007
February 21, 2013
September 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Median increase in CD4+ T-cell count at 48 weeks after starting the HAART combination randomly assigned [ Time Frame: 48 weeks ]
Complete list of historical versions of study NCT00532168 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: tenofovir + emtricitabine + efavirenz
    tenofovir + emtricitabine + efavirenz, approved dose, oral route, QD
  • Drug: tenofovir + emtricitabine + lopinavir-ritonavir
    tenofovir + emtricitabine (QD) + lopinavir-ritonavir (BID), oral route, approved dose
  • Drug: tenofovir + emtricitabine + atazanavir-ritonavir
    tenofovir + emtricitabine + atazanavir + ritonavir (100 mg), oral route, approved dose, QD
  • Experimental: 1
    tenofovir plus emtricitabine plus efavirenz
    Intervention: Drug: tenofovir + emtricitabine + efavirenz
  • Experimental: 2
    tenofovir plus emtricitabine plus lopinavir-ritonavir
    Intervention: Drug: tenofovir + emtricitabine + lopinavir-ritonavir
  • Experimental: 3
    tenofovir plus emtricitabine plus atazanavir-ritonavir
    Intervention: Drug: tenofovir + emtricitabine + atazanavir-ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00532168
ADVANZ-3, EudraCT: 2006-006268-42, FIS grant: EC07/90642
No
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Study Chair: Jose M Miró, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP