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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.

Conditions
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HIV-Associated Lipodystrophy Syndrome

Intervention / Treatment
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* Drug: Standard continuous antiretroviral therapy
* Drug: CD-4 guided therapy interruption
* Drug: Viral load driven treatment interruption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard continuous antiretroviral therapy | Drug: Standard continuous antiretroviral therapy<br> <br> |
| Experimental: 2<br>CD-4 guided interruption arm | Drug: CD-4 guided therapy interruption<br>* Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350<br>|
| Experimental: 3<br>Viral load driven treatment interruption | Drug: Viral load driven treatment interruption<br>* Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb fat content measured by dual X-ray absorptiometry |  | 96 weekks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other body composition analyses |  | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipodystrophy, Treatment interruption, HIV