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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00646984
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008

March 26, 2008
March 28, 2008
January 2002
April 2005   (final data collection date for primary outcome measure)
Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00646984 on ClinicalTrials.gov Archive Site
Other body composition analyses [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-Associated Lipodystrophy Syndrome
  • 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
  • Active Comparator: 1
    Standard continuous antiretroviral therapy
    Intervention: Drug: Standard continuous antiretroviral therapy
  • Experimental: 2
    CD-4 guided interruption arm
    Intervention: Drug: CD-4 guided therapy interruption
  • Experimental: 3
    Viral load driven treatment interruption
    Intervention: Drug: Viral load driven treatment interruption
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
April 2006
April 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected patients
  • On stable antiretroviral therapy
  • Viral load below 200 copies/ml
  • CD4 above 450 cells/mcl during last 3 months

Exclusion Criteria:

  • Weight variation higher than 10% compared with previous stable weight
  • Active (CDC-C) opportunistic events
  • Major depression or schizophrenia under psychiatric treatment
  • Lack of clinical stability
  • Pregnant women or planning pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00646984
TARV-DEM-LD, AEM 01-0480
Yes
Esteban Martinez, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Study Director: Jose M Gatell, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP