Safety and Efficacy Study of Serostim® Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome
Public ClinicalTrials.gov record NCT01077960. 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
Phase III, Multi-Center, Open, 12-Week, Follow-up Safety and Efficacy Study of Serostim® in Subjects With Human Immunodeficiency Virus-Associated Adipose Redistribution Syndrome (HARS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In Serono Study 24380, the antecedent protocol to Study 25373, patients were randomly assigned in a 3.0-to-1.0 ratio to Groups A and B. All patients in Group A received recombinant human growth hormone (Serostim®) 4 mg daily (the "induction" phase) for the first 12 weeks, and then were re-randomized to receive either placebo or Serostim 2 mg on alternate days (roughly equivalent to 1 mg daily) during Weeks 12-36 (the "maintenance" phase). All patients in Group B initially received placebo from baseline to Week 24, and then received Serostim® 4 mg daily from Weeks 24 to 36 (Grunfeld, 2007). In the follow-up Study 25373, any subject who was enrolled in Serono Study 24380 and was assigned to Group A, who fully completed all study visits without a major protocol violation, was eligible to enroll to receive re-treatment with Serostim at a dose of 4 mg daily for 12 weeks. During study 25373, safety was monitored by recording of adverse events and measurement of urinalysis and laboratory blood tests to assess fasting glucose, fasting insulin, and routine biochemistry and hematology parameters. At Week 12 or at the time of study termination, subjects underwent re-assessment of body composition via anthropometry measurements and dual photon absorptiometry (DXA) scanning. In addition, at study termination, measurements of insulin-like growth factor I (IGF-I), insulin-like growth binding protein 3 (IGFBP-3), fasting lipid profile, and oral glucose tolerance testing were obtained.
Study identification
- NCT ID
- NCT01077960
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 126 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Feb 2005 (Type not available)
- Primary completion
- Jan 2006 (Actual)
- Completion
- Jan 2006 (Actual)
- Last update posted
- Aug 7, 2013
2005 – 2006
United States locations
- U.S. sites
- 25
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama/Birmingham | Birmingham | Alabama | — | — |
| Care Clinic | Los Angeles | California | — | — |
| Private Practice | Palm Beach | California | — | — |
| UCSD - AVRC (AntiViralResearchCenter) | San Diego | California | — | — |
| Kaiser Permanente | San Francisco | California | — | — |
| Harbor-UCLA Medical Center | Torrence | California | — | — |
| AIDS Alliance | West Hollywood | California | — | — |
| Circle Medical LLC | Norwalk | Connecticut | — | — |
| Private Practice | Washington D.C. | District of Columbia | — | — |
| Private Practice | Fort Lauderdale | Florida | — | — |
| Care Resources | Miami | Florida | — | — |
| Private Practice | Miami | Florida | — | — |
| Private Practice | North Miami Beach | Florida | — | — |
| Infectious Disease Associates | Sarasota | Florida | — | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | — | — |
| Rush University Medical Center | Chicago | Illinois | — | — |
| Community Research Initiative of New England | Boston | Massachusetts | — | — |
| Tufts University School of Medicine | Boston | Massachusetts | — | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | — | — |
| St. Luke's Roosevelt Hospital | New York | New York | — | — |
| St. Vincents Catholic Medical Center | New York | New York | — | — |
| Weill Medical College of Cornell University | New York | New York | — | — |
| Central Texas Clinical Research | Austin | Texas | — | — |
| IPD Research | Annandale | Virginia | — | — |
| Private Practice | Spokane | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01077960, 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 Aug 7, 2013 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01077960 live on ClinicalTrials.gov.