Strategies of Interruption/Reinitiation of Antiretroviral Therapy 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.
|HIV-Associated Lipodystrophy Syndrome||Drug: Standard continuous antiretroviral therapy Drug: CD-4 guided therapy interruption Drug: Viral load driven treatment interruption||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.|
- Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ]
- Other body composition analyses [ Time Frame: 96 weeks ]
|Study Start Date:||January 2002|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Standard continuous antiretroviral therapy
|Drug: Standard continuous antiretroviral therapy|
CD-4 guided interruption arm
Drug: CD-4 guided therapy interruption
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
Viral load driven treatment interruption
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00646984
|Hospital Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Study Director:||Jose M Gatell, MD||Hospital Clinic of Barcelona|