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Body Composition and Adipose Tissue in HIV

NCT03226821 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-05-19

Study results available
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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. 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.

Conditions

  • HIV Lipodystrophy Syndrome
  • Growth Hormone Deficiency
  • Body Composition

Interventions

DRUG

Tesamorelin

Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Pamela U. Freda, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226821 on ClinicalTrials.gov