Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Body Composition and Adipose Tissue in HIV

NCTNCT03226821Other idAAAR2634Other idR01DK110771

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: lack of availability of the study drug

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 6 participants (actual)
Sponsor: Columbia University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 7 Feb 2018
Primary completion: 30 Apr 2025
Completion: 30 Apr 2025
First posted: 24 Jul 2017
Last update posted: 19 May 2026
Conditions: HIV Lipodystrophy Syndrome · Growth Hormone Deficiency · Body Composition

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph 4
Body Composition and Adipose Tissue in HIV
NCT03226821
7 Feb 2018 to 30 Apr 2025
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TesamorelinDrug

Arms1

Experimental
Tesamorelin
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Hepatic Lipid Content
Time frame · Baseline
Registry description
Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).

Secondary outcomes(4)

Visceral Adipose Tissue (VAT) Mass
Time frame · Baseline
Registry description
Visceral adipose tissue mass (kilograms) will be measured by abdominal MRI.
Change in Relative Gene Expression of CD68 Gene
Time frame · Baseline and 12 months
Registry description
Relative gene expression of CD68 gene in adipose tissue
Change in Relative Gene Expression on TNF-alpha Gene
Time frame · Baseline and 12 months
Registry description
Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue
Change in Resting Energy Expenditure (REE)
Time frame · Baseline and 12 months
Registry description
Resting metabolic rate measured by indirect calorimetry

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline

Hepatic Lipid Content

Group	Value (percent of liver volume)
Tesamorelin	7

Secondary and other outcome results(4)

Secondary outcomeNumber· Baseline

Visceral Adipose Tissue (VAT) Mass

Group	Value (kilograms)
Tesamorelin	6.7

Secondary outcome· Baseline and 12 months

Change in Relative Gene Expression of CD68 Gene

Group	Value
Tesamorelin	not posted

Secondary outcome· Baseline and 12 months

Change in Relative Gene Expression on TNF-alpha Gene

Group	Value
Tesamorelin	not posted

Secondary outcome· Baseline and 12 months

Change in Resting Energy Expenditure (REE)

Group	Value
Tesamorelin	not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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.	0 / 6	0 / 6	0 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 68 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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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