Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT04142047

Conditions

HIV

HIV Infections

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The investigators are studying whether metabolic abnormalities in calf (leg) muscle in older people with and others without HIV are associated with decreased abilities to exercise.

Conditions

HIV

HIV Infections

Study ID

NCT04142047

Start date

Sep 5, 2019

Status verified date

Jun, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants who are >= 60 years of age
  • HIV serostatus positive participants on stable antiretroviral therapy (ART) (no regimen change in last month) with undetectable HIV viral load (<100 copies).
  • HIV serostatus negative participants

Exclusion Criteria:

  • Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent
  • Contraindications to MRI
  • Significant cardiovascular, pulmonary or musculoskeletal or orthopedic disease that significantly limits exercise capacity
  • Significant lower extremity peripheral vascular disease.
  • Weight greater than 350 lbs
  • Cognitive or speech impairments that would limit completion of questionnaires or fatigue reporting.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

HIV

Participants (ages 60 and above) with HIV

Control

Participants (ages 60 and above) without HIV

Primary outcome measure

  • Maximal mitochondrial oxidative capacity (VmaxPCr) [ Time Frame: Baseline ]
  • Rate of PCr decline during plantar flexion exercise [ Time Frame: Baseline ]
  • Six minute walk distance [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Maria Esteban, RN, BSN

410-955-1160mesteba1@jh.edu

Tricia Steinberg, RN, MSN

443-287-3469asteinb3@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Tricia Steinberg, MSN

443-287-3469asteinb3@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-08.