Trials / Terminated
TerminatedNCT01579695
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
A Phase 4, Observational, Multicenter, 10-year Prospective Cohort Safety Study Comparing Subjects With HIV-associated Abdominal Lipohypertrophy Exposed to EGRIFTA® (Tesamorelin for Injection) to a Similar Group of Subjects Not Exposed to EGRIFTA®
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 391 (actual)
- Sponsor
- Theratechnologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tesamorelin for injection | Daily 2 mg subcutaneous injections of Tesamorelin |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2018-05-01
- Completion
- 2018-08-01
- First posted
- 2012-04-18
- Last updated
- 2018-09-11
Locations
31 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01579695. Inclusion in this directory is not an endorsement.