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AzTrials

HIV InfectionsPhase 3NCT00123253

TH9507 in Patients With HIV-Associated Lipodystrophy

A Phase 3 study testing TH9507 in people with HIV Infections and Lipodystrophy, run by Theratechnologies at 42 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Lipodystrophy
What is being tested?
TH9507
How many people
412 participants
Where
42 sitesin 2 countries
Study dates
Jun 2005to Apr 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18 to 65 years inclusive
  • HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for 8 weeks)
  • On stable ART regimen for at least 8 weeks prior to randomization
  • Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
  • For males: waist circumference > 95 cm and waist to hip ratio > 0.94;
  • For females: waist circumference > 94 cm and waist to hip ratio > 0.88.
  • Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
  • Signed informed consent

Who cannot join

  • Body mass index < 20 kg/m2
  • Opportunistic infection; HIV-related disease within 3 months of study.
  • History of malignancy; active neoplasm.
  • Prostate-specific antigen (PSA) >5 ng/mL at screening
  • Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
  • Untreated hypothyroidism
Show all 16Show fewer
  • Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
  • ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting triglycerides > 11.3 mmol/L (0.99 g/dL).
  • Untreated hypertension
  • Change in anti-hyperlipemic regimen within 3 months prior to study
  • Change in testosterone regimen and/or supraphysiological dose of testosterone
  • Estrogen therapy
  • Anoretics/anorexigenics or anti-obesity agents within 3 months of study
  • Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
  • Drug or alcohol dependence or use of methadone within 6 months of study entry
  • Participation in a clinical trial with any investigational drug/device within 30 days of screening.

Trial locations and contacts

42 sites in 2 countries.

42 sites in 2 countries

United States35 sites

  • Infectious Disease Physicians Inc.

    Annandale, Virginia

  • AIDS Research Consortium Atlanta (ARCA)

    Atlanta, Georgia

  • Central Texas Clinical Research

    Austin, Texas

  • Institute of Human Virology

    Baltimore, Maryland

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland

  • Community Research Initiative of New England

    Boston, Massachusetts

  • Massachusetts General Hospital

    Boston, Massachusetts

  • Tufts University School of Medicine

    Boston, Massachusetts

  • Bach & Godofsky

    Bradenton, Florida

  • Northern Healthcare

    Chicago, Illinois

  • Rush University Medical Center

    Chicago, Illinois

  • University of Cincinnati Medical Center

    Cincinnati, Ohio

  • Dallas VA Medical Centre

    Dallas, Texas

  • Office of Dr. Gary Richmond

    Fort Lauderdale, Florida

  • The University of Texas Medical School

    Houston, Texas

  • Indiana University Department of Medicine

    Indianapolis, Indiana

  • UCLA School of Medicine

    Los Angeles, California

  • Care Resource Miami

    Miami, Florida

  • Hennepin County Medical Centre

    Minneapolis, Minnesota

  • AIDS Community Research Initiative of America

    New York, New York

  • Bellevue Hospital Center New York University

    New York, New York

  • St Luke's Roosevelt Hospital Centre

    New York, New York

  • St Vincent Catholic Medical Centre

    New York, New York

  • Orlando Immunology Center

    Orlando, Florida

  • Office of Dr. Michael Somero

    Palm Springs, California

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania

  • Fanno Creek Clinic, LLC

    Portland, Oregon

  • UCSD Medical Center

    San Diego, California

  • Kaiser Permanente

    San Francisco, California

  • Infectious Disease Associates

    Sarasota, Florida

  • Swedish Medical Center

    Seattle, Washington

  • Community Research Initiative of New England (CRI West)

    Springfield, Massachusetts

  • Treasure Coast Infectious Disease Consultant (TDIDC)

    Vero Beach, Florida

  • Capital Medical Associates

    Washington D.C., District of Columbia

  • AIDS Research Alliance

    West Hollywood, California

Other trials in United States

Canada7 sites

  • Southern Alberta Clinic

    Calgary, Alberta

  • Clinique Médicale du Quartier Latin

    Montreal, Quebec

  • Clinique Médicale L'Actuel

    Montreal, Quebec

  • Montreal General Hospital

    Montreal, Quebec

  • Sunnybrook and Women College Health Sciences Centre

    Toronto, Ontario

  • St-Paul's Hospital

    Vancouver, British Columbia

  • Windsor Regional Hospital

    Windsor, Ontario

Other trials in Canada

About this study

Official title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.

Being tested
TH9507
Keywords
HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing factor/Growth hormone releasing hormone, Treatment Experienced
Medical subject headings
HIV Infections, Lipodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TH9507Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visceral adipose tissue (VAT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionNov 2006
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123253
Sponsor's protocol ID
TH9507/III/LIPO/010
Status last verified
Nov 2013
First submitted
20 Jul 2005
Last updated
27 Nov 2013
Results posted
No

Publications

  • 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.

    PubMed 28832410

  • 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.

    PubMed 22495074

  • 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.

    PubMed 20554713

  • 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.

    PubMed 20101189

  • Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007 Dec 6;357(23):2359-70. doi: 10.1056/NEJMoa072375.

    PubMed 18057338

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TH9507 in people with HIV Infections and Lipodystrophy, run by Theratechnologies at 42 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visceral adipose tissue (VAT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00123253, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013; AzTrials last refreshed its copy on 3 Nov 2026.

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