Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100

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: NCT00385957
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : December 15, 2010
Information provided by:
Hospital Clinic of Barcelona

October 10, 2006
October 11, 2006
December 15, 2010
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  • Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.
  • Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.
Same as current
Complete list of historical versions of study NCT00385957 on Archive Site
  • Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive
  • CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)
  • and levels of CD8 cells (CD28+ y CD38+)
  • Incidence of adverse events
Same as current
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Immunological and Viral Response to Antiretrovirals in HIV Patients With CD4 Cell Count Below 100
Comparison of Antiretroviral Activity and Immunological Effect of Two Triple Treatments With and Without Protease Inhibitors in naïve HIV-1-infected Patients With CD4 < 100/mm3
The study analyzes the virological response in plasma and non-plasma compartments, as well as the degree and kinetics of immune reconstitution in 70 treatment-naive patients with CD4 < 100/mm3, when they receive treatment with two nucleoside analogs (NRTI) plus one protease inhibitor (PI) compared with 2 NRTI plus one non-nucleoside (NNRTI).
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
  • Drug: AZT+3TC+IDV+RTV
  • Drug: AZT+3TC+EFV
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Miró JM, Manzardo C, Pich J, Domingo P, Ferrer E, Arribas JR, Ribera E, Arrizabalaga J, Loncá M, Cruceta A, de Lazzari E, Fuster M, Podzamczer D, Plana M, Gatell JM; Advanz Study Group. Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV type 1-infected patients using a nonnucleoside reverse transcriptase inhibitor-based or a boosted protease inhibitor-based antiretroviral regimen: three-year results (The Advanz Trial): a randomized, controlled trial. AIDS Res Hum Retroviruses. 2010 Jul;26(7):747-57. doi: 10.1089/aid.2009.0105.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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Inclusion Criteria:

  • Diagnosed HIV-1 infection.
  • Age 18 years or over.
  • No previous antiretroviral therapy.
  • CD4 lymphocyte count of < 100 cells/mL.
  • Patients who, sufficiently informed, give their written consent to participate in the study and undergo the tests and explorations involved in the study.

Exclusion Criteria:

  • Pregnant women, women who are breast feeding, or women who intend to become pregnant during the study period.
  • Currently undergoing treatment for an opportunistic infection (parenteral administration).
  • Any formal contraindication to treatment with the study drugs
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Hospital Clinic of Barcelona
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Study Chair: Jose M Gatell, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
October 2006

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