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HIV Meds' hidden impact on heart and body fat revealed

NCT ID NCT03059121

Knowledge-focused Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 56 people with HIV who had never taken HIV medication before. Researchers measured changes in body fat, heart function, and blood vessel health after starting treatment. The goal was to understand how HIV therapy might affect long-term heart and metabolic risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

56 people

The number who actually took part.

Started

Sep 2016

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects will be primarily recruited from the practice of the investigator (the Special Immunology Unit (SIU) at University Hospitals Case Medical Center). All subjects seen at the Special Immunology Unit who meet the inclusion/exclusion criteria will be approached for study participation. Subjects who see physicians outside of the SIU may be eligible as well if they contact the study team and meet the inclusion criteria.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test * Provides written informed consent and is capable of reading and comprehending the informed consent * Is not currently taking antiretroviral therapy and has never been on such treatments in the past. Exception would be for subjects who had been in the past on ≤30 days cumulative antiretrovirals, as long as these were stopped \>6 months prior to study entry * Is planning on starting antiretroviral therapy as part of routine clinic care Exclusion Criteria: * Pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

HIV infectious disease lipodystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Lipodystrophy

Contacts and locations

Locations

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.