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

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

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

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 identifier: NCT00385957

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

Publications automatically indexed to this study by Identifier (NCT Number): 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 processed this record on May 23, 2016