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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)
  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
HIV Infections

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 Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Change in Mitochondrial Activity [ Time Frame: Entry, Week 96 ]
    mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA
Blood collection

Enrollment: 56
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ABC/3TC
HIV-infected subjects were given Abacavir-Lamuvidine
TDF/FTC
HIV-infected patients were given tenofovir DF-emtricitabine

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

Information from the National Library of Medicine

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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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433992


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

Additional Information:
Responsible Party: Grace McComsey, Grace McComsey, MD, Case School of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00433992     History of Changes
Other Study ID Numbers: 1R01AI065348-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: March 28, 2017
Results First Posted: July 31, 2017
Last Update Posted: September 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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