Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00433992
First received: February 9, 2007
Last updated: February 22, 2010
Last verified: August 2007

February 9, 2007
February 22, 2010
April 2006
October 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00433992 on ClinicalTrials.gov Archive Site
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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
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00433992
1R01AI065348-01A2, AI065348
Not Provided
Grace McComsey, MD, Case School of Medicine
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)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP