Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
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|ClinicalTrials.gov Identifier: NCT00646984|
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-Associated Lipodystrophy Syndrome||Drug: Standard continuous antiretroviral therapy Drug: CD-4 guided therapy interruption Drug: Viral load driven treatment interruption||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||April 2005|
|Actual Study Completion Date :||April 2006|
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
- Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ]
- Other body composition analyses [ Time Frame: 96 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646984
|Hospital Clinic of Barcelona|
|Barcelona, Spain, 08036|
|Study Director:||Jose M Gatell, MD||Hospital Clinic of Barcelona|