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Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

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

Condition Phase
HIV Infections
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis

Resource links provided by NLM:

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA
Blood collection

Estimated Enrollment: 60
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients who are enrolled in ACTG A5202, starting their first nucleoside reverse transcriptase inhibitor (NRTI)-containing regimen

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00433992

United States, Ohio
Case School of Medicine
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Grace McComsey, MD Case School of Medicine
  More Information

Additional Information:
Responsible Party: Grace McComsey, MD, Case School of Medicine Identifier: NCT00433992     History of Changes
Other Study ID Numbers: 1R01AI065348-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: February 9, 2007
Last Updated: February 22, 2010

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Fat apoptosis
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on May 23, 2017