TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

NCT00608023 | Completed Phase 3 Results

• 1 other identifier: TH9507-CTR-1012
• Study Type: interventional
• Target: 263
• Locations: 6 countries
• Sites: 47

Brief Summary

Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

Conditions

Lipodystrophy; HIV Infections

Keywords

HIV; Lipodystrophy; Abdominal fat accumulation; Growth hormone releasing hormone; HIV-associated lipodystrophy; Treatment 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: Tesamorelin; Drug: Placebo for Tesamorelin

Placebo-Tesamorelin (P-T)

EXPERIMENTAL

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

Drug: Tesamorelin; Drug: Placebo for Tesamorelin

Interventions

Tesamorelin DRUG

Also known as: Egrifta

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

Placebo for Tesamorelin DRUG

Placebo-Tesamorelin (P-T); Tesamorelin-Placebo (T-P)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• Fasting blood glucose \>8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.

Sponsors & Collaborators

• Theratechnologies: lead

Study Sites (47)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-2170, United States

Location

Body Positive Inc.

Phoenix, Arizona, 85006, United States

Location

Somero, Michael

Indio, California, 92201, United States

Location

UCLA School of Medicine

Los Angeles, California, 90035, United States

Location

Office of Dr. Michael Somero

Palm Springs, California, 92262, United States

Location

University of California

San Francisco, California, 94110, United States

Location

Kaiser Permanente

San Francisco, California, 94118, United States

Location

UCSF/VA Medical Center

San Francisco, California, 94121, United States

Location

AIDS Research Alliance

West Hollywood, California, 90069, United States

Location

Denver Public Health Department

Denver, Colorado, 80204-4507, United States

Location

Office of Dr. Gary Richmond

Fort Lauderdale, Florida, 33316, United States

Location

Hendry/Glades County Health Departments

LaBelle, Florida, 33935, United States

Location

Infectious Disease Research Institute Inc.

Tampa, Florida, 33614, United States

Location

AIDS Research Consortium Atlanta (ARCA)

Atlanta, Georgia, 30308, United States

Location

Northern Healthcare

Chicago, Illinois, 60657, United States

Location

Northstar Medical

Chicago, Illinois, 60657, United States

Location

Indiana University Department of Medicine

Indianapolis, Indiana, 46202, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

The Research Institute

Springfield, Massachusetts, 01107, United States

Location

ID Associates

Hillsborough, New Jersey, 08844, United States

Location

AIDS Community Research Initiative of America

New York, New York, 10018, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7215, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75232, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

C. H. U. Sart-Tilman

Liège, 4000, Belgium

Location

St-Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

McMaster University Health Sciences Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier Universitaire de Santé de l'Estrie

Fleurimont, Quebec, J1H 5N4, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Groupe de Recherche en Rhumatologie et maladies osseuses

Ste-Foy, Quebec, G1V 3M7, Canada

Location

Hôpital Hotel Dieu Lyon

Lyon, 69288, France

Location

Hotel Dieu

Nantes, 44093, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Necker

Paris, 75743, France

Location

Hosp. Ramon y Cajal

Madrid, 28034, Spain

Location

Hosp. Clinico San Carlos

Madrid, 28040, Spain

Location

Hosp.C.U.de Santiago

Santiago de Compostela, 15706, Spain

Location

BSUH NHS Trust

Brighton, BN2 1ES, United Kingdom

Location

St Georges Hospital

London, 17 0QT, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9TH, United Kingdom

Location

St Mary's NHS Trust

London, W2 1NY, United Kingdom

Location

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: 28832410 DERIVED

• 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: 22495074 DERIVED

• Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16.

  PMID: 20554713 DERIVED

• Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.

  PMID: 20101189 DERIVED

MeSH Terms

Conditions

Lipodystrophy; HIV Infections; HIV-Associated Lipodystrophy Syndrome

Interventions

tesamorelin

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

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

Mdechantal@theratech.com

1 438-315-6624

Study Officials

• Steven Grinspoon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: September 30, 2022
• Results First Posted: January 15, 2014

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GB (5); CA (7); FR (4); BE (1); US (27)