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
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433992

Locations
United States, Ohio
Case School of Medicine
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Investigators
Principal Investigator: Grace McComsey, MD Case School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Grace McComsey, MD, Case School of Medicine
ClinicalTrials.gov Identifier: NCT00433992     History of Changes
Other Study ID Numbers: 1R01AI065348-01A2, AI065348
Study First Received: February 9, 2007
Last Updated: February 22, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 22, 2014