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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00385957
First received: October 10, 2006
Last updated: December 14, 2010
Last verified: October 2006

October 10, 2006
December 14, 2010
Not Provided
Not Provided
  • 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: AZT+3TC+IDV+RTV
  • Drug: AZT+3TC+EFV
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00385957
ADVAN-Z
Not Provided
Not Provided
Hospital Clinic of Barcelona
Not Provided
Study Chair: Jose M Gatell, MD Hospital Clinic de 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