HIV-Associated Lipodystrophy Syndrome Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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