Back to resultsStrategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Primary Purpose
HIV-Associated Lipodystrophy Syndrome
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Standard continuous antiretroviral therapy
CD-4 guided therapy interruption
Viral load driven treatment interruption
Sponsored by
About this trial
This is an interventional treatment trial for HIV-Associated Lipodystrophy Syndrome focused on measuring Lipodystrophy, Treatment interruption, HIV
Eligibility Criteria
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
Sites / Locations
- Hospital Clinic of Barcelona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Standard continuous antiretroviral therapy
CD-4 guided interruption arm
Viral load driven treatment interruption
Outcomes
Primary Outcome Measures
Limb fat content measured by dual X-ray absorptiometry
Secondary Outcome Measures
Other body composition analyses
Full Information
NCT ID
NCT00646984
First Posted
March 26, 2008
Last Updated
March 28, 2008
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT00646984
Brief Title
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Official Title
Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-Associated Lipodystrophy Syndrome
Keywords
Lipodystrophy, Treatment interruption, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard continuous antiretroviral therapy
Arm Title
2
Arm Type
Experimental
Arm Description
CD-4 guided interruption arm
Arm Title
3
Arm Type
Experimental
Arm Description
Viral load driven treatment interruption
Intervention Type
Drug
Intervention Name(s)
Standard continuous antiretroviral therapy
Intervention Type
Drug
Intervention Name(s)
CD-4 guided therapy interruption
Intervention Description
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
Intervention Type
Drug
Intervention Name(s)
Viral load driven treatment interruption
Intervention Description
Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml
Primary Outcome Measure Information:
Title
Limb fat content measured by dual X-ray absorptiometry
Time Frame
96 weekks
Secondary Outcome Measure Information:
Title
Other body composition analyses
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose M Gatell, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
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