Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

September 1, 2017 updated by: Grace McComsey, National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ABC/3TC
HIV-infected subjects were given Abacavir-Lamuvidine
TDF/FTC
HIV-infected patients were given tenofovir DF-emtricitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mitochondrial Activity
Time Frame: Entry, Week 96
mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.
Entry, Week 96

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Entry, Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Grace McComsey, MD, Case School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 12, 2007

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AI065348-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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