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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
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: AZT+3TC+IDV+RTV
Drug: AZT+3TC+EFV
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 70
  Eligibility

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

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
  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: NCT00385957

Locations
Spain
CSU Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Donostia Ospitaleak
San Sebastian, Giputzkoa, Spain, 20014
Hospital Clinic
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Study Chair: Jose M Gatell, MD Hospital Clinic de Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00385957     History of Changes
Other Study ID Numbers: ADVAN-Z
Study First Received: October 10, 2006
Last Updated: December 14, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
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

ClinicalTrials.gov processed this record on November 23, 2014