Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
NCT ID: NCT01579695
Last Updated: 2018-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
391 participants
OBSERVATIONAL
2013-02-28
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT00608023
Study to Evaluate the Efficacy and Safety of a Rilpivarine-based Antiretroviral Tratment Regimen in HIV- Infected Patients With Liver Metabolic Disease Who Maintain Udetectable HIV Viral Load
NCT05898841
GSK1349572 Hepatic Impairment Study
NCT01231529
TH9507 in Patients With HIV-Associated Lipodystrophy
NCT00123253
Incretin Microdosing for Cardiometabolic Health in People With HIV
NCT07325500
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exposed Group will receive Tesamorelin
Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Control Group will not receive Tesamorelin
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tesamorelin for injection
Daily 2 mg subcutaneous injections of Tesamorelin
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject is an adult man or woman ≥ 18 years old;
3. Subject has HIV infection;
4. Subject has physical evidence of excess abdominal fat, as determined by the examining study physician.
5. Subject has completed standard of care assessments (mammography, cervical PAP smear, colonoscopy and blood work for HIV-1 RNA, CD4 cell count, renal, hepatic, and hematology, PSA test, fasting blood glucose, lipid panel ) prior to being enrolled onto the study.
Exclusion Criteria
2. Active malignancy (newly diagnosed or recurrent)
3. Known hypersensitivity to tesamorelin and/or mannitol
4. Pregnancy or lactation
5. Use of EGRIFTA® within 6 months prior to baseline
6. Failure to complete any standard of care assessments listed in Section 5.2.1
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Theratechnologies
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Claude Mamputu, PhD
Role:
Theratechnologies Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Franco Felizarta, MD
Bakersfield, California, United States
Pacific Coast Medical Group
Fountain Valley, California, United States
University of California CARE Clinic, Los Angeles
Los Angeles, California, United States
Tower Infectious Diseases Medical Associates
Los Angeles, California, United States
Oasis Clinic
Los Angeles, California, United States
VAMC, Infectious Disease Section 111W
San Francisco, California, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
Gary J. Richmond, M.D., PA
Fort Lauderdale, Florida, United States
The Kinder Medical Group-AHF
Miami, Florida, United States
Orange County Health Department
Orlando, Florida, United States
Orange County Health Department
Orlando, Florida, United States
Rowan Tree Medical, P.A.
Wilton Manors, Florida, United States
Absolute Care Medical Center
Atlanta, Georgia, United States
Northstar Medical Center
Chicago, Illinois, United States
Southern Illnois University School of Medicine
Springfield, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
The Researth Institute
Springfield, Massachusetts, United States
Be Well Medical Center, P.C
Berkley, Michigan, United States
Southhampton Clinical Research, Inc. d.b.a. Central West Clinical Research
St Louis, Missouri, United States
Southampton Healthcare, Inc.
St Louis, Missouri, United States
South Jersey Unfectious Disease
Somers Point, New Jersey, United States
University at Buffalo, State University of NY, Erie County Medical Center
Buffalo, New York, United States
Ricky K. Hsu, MD, PC
New York, New York, United States
Summa Health Care System
Akron, Ohio, United States
Virginia Mason Medical Center
Tulsa, Oklahoma, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States
St. Hope Foundation, Inc.
Bellaire, Texas, United States
Dallas VA Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EMR200147-501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.