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Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy

NCT00646984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2008-03-31

No results posted yet for this study

Summary

Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.

Design: Pilot, prospective, open, randomized, controlled 3-year study.

Setting and patients: University hospital. Patients with viral load \<200 copies/mL and CD4 cell count \>450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.

Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA \>200 copies/mL while on therapy), immunological failure (CD4 cell count \<200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.

Conditions

  • HIV-Associated Lipodystrophy Syndrome

Interventions

DRUG

Standard continuous antiretroviral therapy

DRUG

CD-4 guided therapy interruption

Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350

DRUG

Viral load driven treatment interruption

Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Jose M Gatell, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2005-04-30
Completion
2006-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00646984 on ClinicalTrials.gov