Trial · NCT00608023
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT00608023, Phase 3, Completed, Theratechnologies; results first posted 2014-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy. Trials, record NCT00608023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
- NCT number
- NCT00608023
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 263 participants, actual
- Lead sponsor
- Theratechnologies
- Conditions
- Lipodystrophy, HIV Infections
- Interventions
- Tesamorelin, Placebo for Tesamorelin
- First posted
- 2008-02-06
- Last updated
- 2022-09-30
- Results first posted
- 2014-01-15
- 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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes From Baseline in Fasting Blood Glucose at Week 52 | Baseline and Week 52 | Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported. |
| Primary | Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 | Baseline and 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. |
| Secondary | Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Baseline and Week 52 | 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. |
| Other | Changes From Baseline in Triglycerides at Week 52 | Baseline and Week 52 | Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported. |
| Other | Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Baseline and Week 52 | Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Baseline and Week 52 | All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug). | cm^2 | MEAN |
| OTHER_PRE_SPECIFIED | Changes From Baseline in Triglycerides at Week 52 | Baseline and Week 52 | mg/dL | MEAN | |
| OTHER_PRE_SPECIFIED | Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Baseline and Week 52 | ratio | MEAN | |
| PRIMARY | Changes From Baseline in Fasting Blood Glucose at Week 52 | Baseline and Week 52 | mg/dL | MEAN | |
| PRIMARY | Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 | Baseline and Week 52 | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Tesamorelin 52 Weeks | -41 | Standard Deviation 57 | cm^2 | |
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 0 | Standard Deviation 53 | cm^2 | |
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | -26 | Standard Deviation 47 | cm^2 | |
| Changes From Baseline in Triglycerides at Week 52 | Tesamorelin (52 Weeks) | -37 | Standard Deviation 196 | mg/dL | |
| Changes From Baseline in Triglycerides at Week 52 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 4 | Standard Deviation 177 | mg/dL | |
| Changes From Baseline in Triglycerides at Week 52 | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 1 | Standard Deviation 120 | mg/dL | |
| Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Tesamorelin 52 Weeks | -0.23 | Standard Deviation 1.75 | ratio | |
| Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 0.13 | Standard Deviation 1.19 | ratio | |
| Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 0.06 | Standard Deviation 1.01 | ratio | |
| Changes From Baseline in Fasting Blood Glucose at Week 52 | Tesamorelin 52 Weeks | 0 | Standard Deviation 16 | mg/dL |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tesamorelin (52 Weeks) | 92 | |
| Overall Study | STARTED | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 85 | |
| Overall Study | STARTED | Placebo-Tesamorelin (P-T) | 86 | |
| Overall Study | COMPLETED | Tesamorelin (52 Weeks) | 80 | |
| Overall Study | COMPLETED | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 63 | |
| Overall Study | COMPLETED | Placebo-Tesamorelin (P-T) | 72 | |
| Overall Study | NOT COMPLETED | Tesamorelin (52 Weeks) | 12 | |
| Overall Study | NOT COMPLETED | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 22 | |
| Overall Study | NOT COMPLETED | Placebo-Tesamorelin (P-T) | 14 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Tesamorelin 52 Weeks | 3 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 4 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 5 | 86 | |
| other | Injection site erythema | General disorders | Tesamorelin 52 Weeks | 3 | 92 | |
| other | Injection site erythema | General disorders | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 0 | 85 | |
| other | Injection site erythema | General disorders | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 5 | 86 | |
| other | Injection site pain | General disorders | Tesamorelin 52 Weeks | 0 | 92 | |
| other | Injection site pain | General disorders | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 0 | 85 | |
| other | Injection site pain | General disorders | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 5 | 86 | |
| other | Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Tesamorelin 52 Weeks | 8 | 92 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tesamorelin 52 Weeks | ||
| Total, all-cause mortality | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | ||
| Total, all-cause mortality | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | ||
| Total, other adverse events | Tesamorelin 52 Weeks | 17 | 92 |
| Total, other adverse events | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 11 | 85 |
| Total, other adverse events | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 28 | 86 |
| Total, serious adverse events | Tesamorelin 52 Weeks | 3 | 92 |
| Total, serious adverse events | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | 1 | 85 |
| Total, serious adverse events | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | 3 | 86 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00608023
GET https://conductscience.org/api/trials/v1/NCT00608023/events?page=2