Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

HIVLipodystrophyAbdominal fat accumulationGrowth hormone releasing hormoneHIV-associated lipodystrophyTreatment experienced

Outcome Measures

Primary Outcomes (2)

Changes From Baseline in Fasting Blood Glucose at Week 52
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Baseline and Week 52
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.
Baseline and Week 52

Secondary Outcomes (1)

Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Baseline and Week 52

Other Outcomes (2)

Changes From Baseline in Triglycerides at Week 52
Baseline and Week 52
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Baseline and Week 52

Study Arms (3)

Tesamorelin 12 months (T-T)

EXPERIMENTAL

Tesamorelin 2 mg/day for 12 months

Drug: Tesamorelin

Tesamorelin-Placebo (T-P)

EXPERIMENTAL

Tesamorelin 2 mg/day for 6 months - Placebo for 6 months

Drug: TesamorelinDrug: Placebo for Tesamorelin

Placebo-Tesamorelin (P-T)

EXPERIMENTAL

Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Interventions

TesamorelinDrug

Also known as: Egrifta

Placebo-Tesamorelin (P-T)Tesamorelin 12 months (T-T)Tesamorelin-Placebo (T-P)

Placebo for TesamorelinDrug

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
Signed informed consent before any trial-related activities.

You may not qualify if:

Sponsors & Collaborators

Theratechnologies
Industrylead

Study Sites (47)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2170, United States

Body Positive Inc.

Phoenix, Arizona, 85006, United States

Somero, Michael

Indio, California, 92201, United States

UCLA School of Medicine

Los Angeles, California, 90035, United States

Office of Dr. Michael Somero

Palm Springs, California, 92262, United States

University of California

San Francisco, California, 94110, United States

Kaiser Permanente

San Francisco, California, 94118, United States

Related Publications (4)

Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.
PMID: 28832410DERIVED
Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10.
PMID: 22495074DERIVED

MeSH Terms

Conditions

LipodystrophyHIV InfectionsHIV-Associated Lipodystrophy Syndrome

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Skin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, Viral

Limitations and Caveats

As this trial was completed in October 2008 hence, the primary Completion Date is prior to January 18, 2017, therefore the Protocol, and Statistical Analysis Plan have not been uploaded to the Document Section.

Results Point of Contact

Title: Marilyn de Chantal, Global Senior Medical Director
Organization: Theratechnologies

Study Officials

Steven Grinspoon, MD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: LTE60
Restrictive Agreement: Yes

Enrollment

263 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

August 2007

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Other Outcomes (2)

Study Arms (3)

Tesamorelin 12 months (T-T)

Tesamorelin-Placebo (T-P)

Placebo-Tesamorelin (P-T)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (47)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations