Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
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|ClinicalTrials.gov Identifier: NCT00433992|
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : July 31, 2017
Last Update Posted : September 5, 2017
|Condition or disease|
The main objective of this study is to observe the effects of anti-HIV medication lacking thymidine on mitochondrial metabolism and adipocyte apoptosis (fat cell death). Changes in mitochondrial metabolism and increases in adipocyte apoptosis are associated with lipoatrophy. Lipoatrophy is a common condition characterized by loss of subcutaneous fat and can be caused by many anti-HIV medications. This study will examine the metabolic consequences of the use of thymidine analogue-sparing treatment regimens.
This study will evaluate HIV infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen. This regimen will include either tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC), which are thymidine-sparing regimens. The changes in mitochondrial activity and fat cell death will be compared between participants taking thymidine-sparing regimens (TDF/FTC or ABC/3TC) and thymidine-containing regimens.
This study will last for 96 weeks, with two study visits occurring at entry and another visit at Week 96. During each visit, a dual energy x-ray absorptiometry (DEXA) scan and blood collection will occur, and a fat biopsy will be performed in the lower abdomen under local anesthetic.
|Study Type :||Observational|
|Actual Enrollment :||56 participants|
|Official Title:||Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
HIV-infected subjects were given Abacavir-Lamuvidine
HIV-infected patients were given tenofovir DF-emtricitabine
- Change in Mitochondrial Activity [ Time Frame: Entry, Week 96 ]mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
- Change in Fat Apoptosis [ Time Frame: Entry, Week 48 ]Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry
Biospecimen Retention: Samples With DNA
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): NCT00433992
|United States, Ohio|
|Case School of Medicine|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||Case School of Medicine|