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Can a daily injection reshape bodies of HIV patients?

NCT ID NCT03226821

Disease control Sponsor: Columbia University 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at whether tesamorelin (Egrifta), a daily injection that boosts growth hormone, can improve body composition in people with HIV who have excess belly fat (lipodystrophy). Six participants received the drug for up to 12 months, with researchers measuring liver fat, belly fat, and insulin sensitivity. The trial was terminated early, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tesamorelin (Egrifta) - a daily injection that mimics growth hormone releasing hormone
What this could lead to
If it works, this could help reduce belly fat and improve body shape in people with HIV-related lipodystrophy.
What could go wrong
This is a very small study (only 6 people) that was terminated early, so results may not be reliable. Tesamorelin can cause joint pain, swelling, or injection site reactions.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

6 people

The number who actually took part.

Started

Feb 2018

Finished

Apr 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.

Ages

18 to 68 years

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-infected subjects with HIV lipodystrophy (HIVLD) * Abdominal fat accumulation defined as: Waist Circumference (WC) 102 cm for men, 88 cm for women, except in subjects of East/South Asian ethnicity in whom this will be defined by WC 90 cm for men and 80 cm for women. * Weight stable for 8 weeks prior to enrollment, * CD4 count \>100 cells/mm3 * HIV RNA load \<1000 copies/mL * Fasting plasma glucose \<120 mg/dL * Stable combination anti-retroviral therapy (cART) of any regimen for ≥ 8 weeks prior to study enrollment Exclusion Criteria: * Diabetes mellitus requiring medication * History of any malignancy * Abnormal renal or liver function * Pregnancy or women of childbearing age who are not using an acceptable means of contraception * History disorder of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery * Head irradiation or head trauma or adrenal insufficiency * Systemic glucocorticoid use * Known hypersensitivity to tesamorelin and/or mannitol

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Conditions

The condition(s) this trial relates to.

HIV-Associated Lipodystrophy Syndrome isolated congenital growth hormone deficiency pituitary dwarfism

As listed by the trial registrant

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

Body composition Growth hormone deficiency HIV lipodystrophy syndrome

Contacts and locations

Locations

  • Neuroendocrine Unit and Pituitary Center, Columbia University

    New York, New York, 10032, United States

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