Trial Outcomes & Findings for Body Composition and Adipose Tissue in HIV (NCT NCT03226821)

Results Overview

Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Baseline

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study did not receive study drug	5
Overall Study Lost to Follow-up	1

Baseline Characteristics

Body Composition and Adipose Tissue in HIV

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tesamorelin n=6 Participants 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.
Age, Continuous	51.5 years n=30 Participants
Sex: Female, Male Female	2 Participants n=30 Participants
Sex: Female, Male Male	4 Participants n=30 Participants
Race/Ethnicity, Customized White, not Hispanic	2 Participants n=30 Participants
Race/Ethnicity, Customized Black not Hispanic	3 Participants n=30 Participants
Race/Ethnicity, Customized White, Hispanic	1 Participants n=30 Participants
Region of Enrollment United States	6 Participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Due to lack of availability of the study drug leading to early study termination, only 3 participants were assessed for this outcome at baseline only.

Hepatic lipid content (percent) will be measured by abdominal magnetic resonance imaging (MRI).

Outcome measures

Outcome measures
Measure	Tesamorelin n=3 Participants 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.
Hepatic Lipid Content Subject 1	7 percent of liver volume
Hepatic Lipid Content Subject 2	3.58 percent of liver volume
Hepatic Lipid Content Subject 3	1.09 percent of liver volume

SECONDARY outcome

Timeframe: Baseline

Population: Due to lack of availability of the study drug leading to early study termination, only 3 participants were assessed for this outcome at baseline only.

Visceral adipose tissue mass (kilograms) will be measured by abdominal MRI.

Outcome measures

Outcome measures
Measure	Tesamorelin n=3 Participants 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.
Visceral Adipose Tissue (VAT) Mass Subject 1	6.7 kilograms
Visceral Adipose Tissue (VAT) Mass Subject 2	5.9 kilograms
Visceral Adipose Tissue (VAT) Mass Subject 3	3.6 kilograms

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Due to lack of availability of the study drug, the study was terminated before any planned data could be collected for this outcome.

Relative gene expression of CD68 gene in adipose tissue

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Due to lack of availability of the study drug, the study was terminated before any planned data could be collected for this outcome.

Relative gene expression of tumor necrosis factor (TNF)-alpha gene in adipose tissue

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Due to lack of availability of the study drug, the study was terminated before any planned data could be collected for this outcome.

Resting metabolic rate measured by indirect calorimetry

Outcome measures

Outcome data not reported

Adverse Events

Tesamorelin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pamela U. Freda, MD

Columbia University

Phone: 212 305 2254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place