TH9507 in Patients With HIV-Associated Lipodystrophy
Public ClinicalTrials.gov record NCT00123253. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00123253
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 412 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2005 (Type not available)
- Primary completion
- Nov 2006 (Actual)
- Completion
- Apr 2007 (Actual)
- Last update posted
- Nov 27, 2013
2005 – 2007
United States locations
- U.S. sites
- 35
- U.S. states
- 16
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA School of Medicine | Los Angeles | California | — | — |
| Office of Dr. Michael Somero | Palm Springs | California | — | — |
| UCSD Medical Center | San Diego | California | — | — |
| Kaiser Permanente | San Francisco | California | — | — |
| AIDS Research Alliance | West Hollywood | California | — | — |
| Capital Medical Associates | Washington D.C. | District of Columbia | — | — |
| Bach & Godofsky | Bradenton | Florida | — | — |
| Office of Dr. Gary Richmond | Fort Lauderdale | Florida | — | — |
| Care Resource Miami | Miami | Florida | — | — |
| Orlando Immunology Center | Orlando | Florida | — | — |
| Infectious Disease Associates | Sarasota | Florida | — | — |
| Treasure Coast Infectious Disease Consultant (TDIDC) | Vero Beach | Florida | — | — |
| AIDS Research Consortium Atlanta (ARCA) | Atlanta | Georgia | — | — |
| Northern Healthcare | Chicago | Illinois | — | — |
| Rush University Medical Center | Chicago | Illinois | — | — |
| Indiana University Department of Medicine | Indianapolis | Indiana | — | — |
| 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 | — | — |
| Community Research Initiative of New England (CRI West) | Springfield | Massachusetts | — | — |
| 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 | — | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | — | — |
| Fanno Creek Clinic, LLC | Portland | Oregon | — | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | — | — |
| Central Texas Clinical Research | Austin | Texas | — | — |
| Dallas VA Medical Centre | Dallas | Texas | — | — |
| The University of Texas Medical School | Houston | Texas | — | — |
| Infectious Disease Physicians Inc. | Annandale | Virginia | — | — |
| Swedish Medical Center | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00123253, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 27, 2013 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00123253 live on ClinicalTrials.gov.