Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
![](https://webarchive.library.unt.edu/web/20130309095514im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 | Intervention | 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 |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy. |
- Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ] [ Designated as safety issue: Yes ]
- Other body composition analyses [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Enrollment: | 147 |
Study Start Date: | January 2002 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: 1
Standard continuous antiretroviral therapy
|
Drug: Standard continuous antiretroviral therapy |
Experimental: 2
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
|
Experimental: 3
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
|
![](https://webarchive.library.unt.edu/web/20130309095514im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20130309095514im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130309095514im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Esteban Martinez, Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00646984 History of Changes |
Other Study ID Numbers: | TARV-DEM-LD, AEM 01-0480 |
Study First Received: | March 26, 2008 |
Last Updated: | March 28, 2008 |
Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Hospital Clinic of Barcelona:
Lipodystrophy Treatment interruption HIV |
Additional relevant MeSH terms:
Lipodystrophy HIV-Associated Lipodystrophy Syndrome Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases HIV Infections Lentivirus Infections |
Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on March 07, 2013