Mitochondria in HIV and Aging (MITO+)

Completed

• Conditions: Mitochondrial Diseases; Human Immunodeficiency Virus (HIV)

• Registration Number: NCT03489421
• Lead Sponsor: University of Colorado, Denver

Brief Summary

Older adults with human immunodeficiency virus (HIV) and a long history of antiretroviral therapy have more mitochondrial dysfunction- the cells that help them make energy. This dysfunction in mitochondria may lead to symptoms of muscle fatigue, physical function impairment, and impaired exercise tolerance compared to HIV-uninfected controls of a similar age and body mass index (BMI). Furthermore, the investigators hypothesize that the older antiretroviral therapy (ART) of tenofovir disoproxil fumarate (TDF) is associated with greater impairment in mitochondrial function than the newer agent, tenofovir alafenamide (TAF).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-25
• Study First Submitted QC: 2018-03-29
• Study First Posted: 2018-04-05
• Study Start: 2018-12-15
• Status Verified: 2019-09
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-05
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADP/ATP measurement (mitochondrial function)	At Baseline	ADP/ATP ratio between HIV-infected and uninfected subjects

Secondary Outcome Measures

Name	Time	Method
Muscle function	At Baseline	Relationship between measures of muscle function (strength, physical function) and mitochondrial function
Respiratory control ratio (RCR)	At Baseline	Respiratory control ratio (RCR) between HIV-infected and uninfected subjects
Inflammatory markers	At Baseline	Relationship between markers of inflammation (final panel to be determined, but most likely sTNFR1 and 2 in addition to multiplex panel of IL-6, IL-10, CRP, IFN-G) and their effect on mitochondrial function
TDF to TAF change	At Baseline	A separate group of participants changing from TDF-based ART to TAF-based ART will also have mitochondrial function measures before and after change. The inclusion criteria are similar except the age range is 18-70.
Protein citrate synthase	At Baseline	Total protein citrate synthase between HIV-infected and seronegative subjects

Trial Locations

Locations (1)

University of Colorado - Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States