Metabolic Effects of Non-Thymidine Analogue Anti-HIV Medications

HIV Infections Clinical Trial

Official title:

Effects of Thymidine Sparing Regimens on Mitochondrial Metabolism and Adipocyte Apoptosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433992
• Other study ID #: 1R01AI065348-01A2
• Status: Completed
• Phase: N/A
• First received: February 9, 2007
• Last updated: September 1, 2017
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
United States	Case School of Medicine	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mitochondrial Activity	mtDNA content in adipose tissue was measured by quantitative real-time polymerase chain-reaction.	Entry, Week 96
Secondary	Change in Fat Apoptosis	Changes in limb fat from 0 to 48 weeks measured with whole-body dual-energy x-ray absorptiometry	Entry, Week 48

External Links

•   Click here for more information on ACTG A5202 and ACTG 5224
•   Click here for more information on lipodystrophy