Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis|
|Study Start Date:||April 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433992
|United States, Ohio|
|Case School of Medicine|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Grace McComsey, MD||Case School of Medicine|