Trial · Interventional

CompletedPhase 3Results postedRegistry data

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

NCTNCT00608023Other idTH9507-CTR-1012

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 263 participants (actual)
Sponsor: Theratechnologies · Industry
Design: Randomized · Quadruple masking
Countries: 6 countries
United States, Belgium, Canada, France, Spain, United Kingdom
Start: Aug 2007
Primary completion: Oct 2008
Completion: Oct 2008
First posted: 6 Feb 2008 (estimated)
Last update posted: 30 Sept 2022
Conditions: Lipodystrophy · HIV Infections

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009

Ph 3
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT00608023
Aug 2007 to Oct 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

TesamorelinDrug
Placebo for TesamorelinDrug

Arms3

Experimental
Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Experimental
Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Experimental
Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Primary outcomes2

Outcomes the sponsor listed as primary.

Changes From Baseline in Fasting Blood Glucose at Week 52
Time frame · Baseline and Week 52
Registry description
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Time frame · Baseline and Week 52
Registry description
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.

Secondary outcomes(1)

Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Time frame · Baseline and Week 52
Registry description
Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and Week 52

Changes From Baseline in Fasting Blood Glucose at Week 52

Group	Value (mg/dL)	Spread
Tesamorelin 52 Weeks	0	16
Tesamorelin (26 Weeks) - Placebo (26 Weeks)	-2	34
Placebo (26 Weeks) - Tesamorelin (26 Weeks)	1	21

Primary outcomeMean· Baseline and Week 52

Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52

Group	Value (mg/dL)	Spread
Tesamorelin 52 Weeks	-2	38
Tesamorelin (26 Weeks) - Placebo (26 Weeks)	2	35
Placebo (26 Weeks) - Tesamorelin (26 Weeks)	7	37

Secondary and other outcome results(3)

Secondary outcomeMean· Baseline and Week 52

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

Group	Value (cm^2)	Spread
Tesamorelin 52 Weeks	-41	57
Tesamorelin (26 Weeks) - Placebo (26 Weeks)	0	53
Placebo (26 Weeks) - Tesamorelin (26 Weeks)	-26	47

Other pre specified outcomeMean· Baseline and Week 52

Changes From Baseline in Triglycerides at Week 52

Group	Value (mg/dL)	Spread
Tesamorelin (52 Weeks)	-37	196
Tesamorelin (26 Weeks) - Placebo (26 Weeks)	4	177
Placebo (26 Weeks) - Tesamorelin (26 Weeks)	1	120

Other pre specified outcomeMean· Baseline and Week 52

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

Group	Value (ratio)	Spread
Tesamorelin 52 Weeks	-0.23	1.75
Tesamorelin (26 Weeks) - Placebo (26 Weeks)	0.13	1.19
Placebo (26 Weeks) - Tesamorelin (26 Weeks)	0.06	1.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Tesamorelin 52 WeeksTesamorelin 2 mg/day for 52 weeks	–	3 / 92	17 / 92
Tesamorelin (26 Weeks) - Placebo (26 Weeks)Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks	–	1 / 85	11 / 85
Placebo (26 Weeks) - Tesamorelin (26 Weeks)Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks	–	3 / 86	28 / 86

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

PubMed tag: none · 2017

3 results

Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV.

Fourman et al. 2017AIDS (London, England)cited by 10

PMID 28832410PMC5633509DOI 10.1097/qad.0000000000001614PUB-28832410

Rights unknown3 results

Source link See results (3)

Indexing hint: Randomized controlled trial · 2012

5 results

Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.

Stanley et al. 2012Clinical infectious diseases : an official publication of the Infectious Diseases Society of Americacited by 23

PMID 22495074PMC3348954DOI 10.1093/cid/cis251PUB-22495074

Rights unknown5 results

Source link See results (5)

Indexing hint: Randomized controlled trial · 2010

13 results

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.

Falutz et al. 2010Journal of acquired immune deficiency syndromes (1999)cited by 51

PMID 20101189DOI 10.1097/qai.0b013e3181cbdaffPUB-20101189

Rights unknown13 results

Source link See results (13)

PubMed tag: none · 2010

15 results

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.

Falutz et al. 2010The Journal of clinical endocrinology and metabolismcited by 78

PMID 20554713DOI 10.1210/jc.2010-0490PUB-20554713

Full text at the publisher15 results

Publisher page See results (15)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study. * Signed informed consent before any trial-related activities. Exclusion Criteria: * Fasting blood glucose \>8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.

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