Clinical Trial: Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.
Brief 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.
Detailed Summary:
Sponsor: Hospital Clinic of Barcelona
Current Primary Outcome: Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Other body composition analyses [ Time Frame: 96 weeks ]
Original Secondary Outcome: Same as current
Information By: Hospital Clinic of Barcelona
Dates:
Date Received: March 26, 2008
Date Started: January 2002
Date Completion:
Last Updated: March 28, 2008
Last Verified: March 2008
