HIV Lipodystrophy SyndromePhase 4NCT03226821
Body Composition and Adipose Tissue in HIV
A Phase 4 study testing Tesamorelin in people with HIV Lipodystrophy Syndrome and Growth Hormone Deficiency, run by Columbia University at 1 site in United States.
Trial summary
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition
- What is being tested?
- Tesamorelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 30 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuroendocrine Unit and Pituitary Center, Columbia University
New York, New York, 10032
About this study
Official title: Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.
Read the detailed description
HIV lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of HIV treatment. In the HIV lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (VAT) is increased and this is associated with reduced growth hormone (GH) secretion. Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease. The etiology of HIV lipodystrophy (HIVLD) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cART) use. VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients. This body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with HIV lipodystrophy. Patients with HIVLD and central adiposity have been shown to have reduced GH secretion. Thus, a medication has been developed to augment GH secretion. This medication is tesamorelin. GH supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.
- Being tested
- Tesamorelin
- Keywords
- HIV Lipodystrophy, Tesamorelin, Body Composition, Visceral Adiposity
- Medical subject headings
- HIV-Associated Lipodystrophy Syndrome, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
Also called Egrifta
Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
| Study group | Role | What they receive |
|---|---|---|
| Tesamorelin | Experimental | Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit. Receives: Drug: Tesamorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Lipid Content
Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).
Measured: Baseline
Secondary outcomes (4)
Visceral Adipose Tissue (VAT) Mass
Visceral adipose tissue mass (kilograms) will be measured by abdominal MRI.
Measured: Baseline
Change in Relative Gene Expression of CD68 Gene
Relative gene expression of CD68 gene in adipose tissue
Measured: Baseline and 12 months
Change in Relative Gene Expression on TNF-alpha Gene
Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue
Measured: Baseline and 12 months
Change in Resting Energy Expenditure (REE)
Resting metabolic rate measured by indirect calorimetry
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start7 Feb 2018
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: lack of availability of the study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV Lipodystrophy SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela U. Freda, Columbia University
- Investigators
- Pamela U. Freda, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226821
- Sponsor's protocol ID
- AAAR2634
- Other IDs
- R01DK110771
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2017
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Adipose Tissue in HIV Lipodystrophy: Effects of Tesamorelin Therapy
- ClinicalTrials.gov ID
- NCT03226821
- Acronym / sponsor ID
- AAAR2634
- Keywords
- HIV Lipodystrophy, Tesamorelin, Body Composition, Visceral Adiposity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of availability of the study drug
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 19 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.
Detailed description
HIV lipodystrophy is increasingly recognized as a common and clinically significant long-term sequelae of HIV treatment. In the HIV lipodystrophy lipohypertrophy phenotype, visceral adipose tissue (VAT) is increased and this is associated with reduced growth hormone (GH) secretion. Mounting evidence also links this phenotype with dyslipidemia, insulin resistance, subclinical atherosclerosis and cardiovascular (CV) disease in patients with HIV disease. The etiology of HIV lipodystrophy (HIVLD) with central adiposity is unclear, but this phenotype is increasingly common with newer, less lipotoxic combination anti-retroviral therapy (cART) use. VAT and hepatic lipid accumulation, are important health concerns for HIVLD patients. This body composition pattern may contribute to the increased cardiovascular risk that has been demonstrated in patients with HIV lipodystrophy. Patients with HIVLD and central adiposity have been shown to have reduced GH secretion. Thus, a medication has been developed to augment GH secretion. This medication is tesamorelin. GH supplementation in other clinical settings has been shown to reduce visceral adiposity and may reduce hepatic lipid content.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tesamorelin | Experimental | Drug: TesamorelinSubjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesamorelinAlso: EgriftaPatients will be treated with tesamorelin 2 mg by subcutaneous injection daily | Drug | Tesamorelin |
Primary outcome
Hepatic Lipid Content
Time frame: Baseline
Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).
4 secondary outcomes
Visceral Adipose Tissue (VAT) Mass
Time frame: Baseline
Change in Relative Gene Expression of CD68 Gene
Time frame: Baseline and 12 months
Change in Relative Gene Expression on TNF-alpha Gene
Time frame: Baseline and 12 months
Change in Resting Energy Expenditure (REE)
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV Lipodystrophy Syndrome
RecruitingObservational study
The LD Lync Study - Natural History Study of Lipodystrophy Syndromes
Lipodystrophy (Genetic or Acquired, Non HIV)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela U. Freda, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tesamorelin in people with HIV Lipodystrophy Syndrome and Growth Hormone Deficiency, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic Lipid Content (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.