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Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433992
First Posted: February 12, 2007
Last Update Posted: September 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID)
February 9, 2007
February 12, 2007
March 28, 2017
July 31, 2017
September 4, 2017
April 2006
October 2009   (Final data collection date for primary outcome measure)
Change in Mitochondrial Activity [ Time Frame: Entry, Week 96 ]
mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
Not Provided
Complete list of historical versions of study NCT00433992 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications
Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis
The purpose of this study is to observe the effects of certain anti-HIV medications on mitochondrial activity and fat cell death. This study will enroll participants from another study, ACTG A5202, who are on treatment regimens that do not include zidovudine, stavudine, or other thymidine-containing anti-HIV medications.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Blood collection
Non-Probability Sample
HIV-infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen
HIV Infections
Not Provided
  • ABC/3TC
    HIV-infected subjects were given Abacavir-Lamuvidine
  • TDF/FTC
    HIV-infected patients were given tenofovir DF-emtricitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
December 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected
  • Enrolling in ACTG A5202 and its metabolic substudy ACTG A5224

Exclusion Criteria:

  • Bleeding problems
  • Cannot undergo fat biopsies
  • Require aspirin anytime in the 7-day period prior to each biopsy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00433992
1R01AI065348-01A2( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Principal Investigator: Grace McComsey, MD Case School of Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
September 2017