Skip to main content
OpenTrials
Completed

NCT Number: NCT00385957

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZT+3TC+IDV+RTV

Drug

AZT+3TC+EFV

Drug

Primary outcomes

  1. Proportion of patients with VL below 20 copies/ml in plasma at 12 and 24 months.

  2. Proportion of patients with a CD4 count higher than 200 cells/ml at 12 and 24 months.

Secondary outcomes

  1. Immunophenotypic response at 12 and 24 months (CD4:CD8 quotient,levels of naive

  2. CD4 cells (CD45RA+CD45RO-) and memory cells (CD45RA-CD45RO+)

  3. and levels of CD8 cells (CD28+ y CD38+)

  4. Incidence of adverse events

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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

Important dates

First posted
Oct 11, 2006
Registry last updated
Dec 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.