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NCT00123253 · ClinicalTrials.gov registry record · Phase 3
TH9507 in Patients With HIV-Associated Lipodystrophy
A Phase 3 study, sponsored by Theratechnologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 412
- Enrollment target
NCT00123253 is a Phase 3 study that has completed, run by Theratechnologies. The registered enrollment target is 412 participants.
The verdict
NCT00123253, a Phase 3 study, has completed, sponsored by Theratechnologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 412 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG TH9507
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00123253
The ClinicalTrials.gov registry entry for NCT00123253 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Theratechnologies, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TH9507 is the first listed.
NCT00123253 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00123253 about?
NCT00123253 is a clinical study titled "TH9507 in Patients With HIV-Associated Lipodystrophy". 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 rand...
What is the current status of trial NCT00123253?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2005-06. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00123253?
The interventions under investigation include: TH9507 (DRUG).
Who is sponsoring clinical trial NCT00123253?
This trial is sponsored by Theratechnologies, which has 7 total clinical trials registered on ClinicalTrials.gov.
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