Trials Sponsors Conditions Drugs Pricing

Conditions

Body Composition Growth Hormone Deficiency HIV Lipodystrophy Syndrome

Keywords

HIV LipodystrophyTesamorelinBody CompositionVisceral Adiposity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

Visceral Adipose Tissue (VAT) Mass
Baseline
Change in Relative Gene Expression of CD68 Gene
Baseline and 12 months
Change in Relative Gene Expression on TNF-alpha Gene

Study Arms (1)

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.

Drug: Tesamorelin

Interventions

TesamorelinDrug

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

Also known as: Egrifta

Tesamorelin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 68 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHcollaborator
Columbia University
Otherlead

Study Sites (1)

Neuroendocrine Unit and Pituitary Center, Columbia University

New York, New York, 10032, United States

MeSH Terms

Conditions

HIV-Associated Lipodystrophy SyndromeDwarfism, Pituitary

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital Diseases

Results Point of Contact

Title: Pamela U. Freda, MD
Organization: Columbia University

Study Officials

Pamela U. Freda, MD
Columbia University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Medicine

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 24, 2017

Study Start

February 7, 2018

Actual (reported)

Study Stopped

Body Composition and Adipose Tissue in HIV

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Tesamorelin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Body Composition and Adipose Tissue in HIV

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Tesamorelin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations