Skip to content

Trial · Observational

TerminatedPhase not statedRegistry data

Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®

NCTNCT01579695 (opens ClinicalTrials.gov in a new tab)Other idEMR200147-501
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase not stated
Enrollment
391 participants (actual)
Sponsor
Theratechnologies · Industry
Design
Not stated
Countries
1 country

United States

Start
Feb 2013
Primary completion
May 2018
Completion
Aug 2018
First posted
18 Apr 2012 (estimated)
Last update posted
11 Sept 2018
Conditions
HIV

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016201720182019
  1. Ph –

    Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®

    NCT01579695

    Feb 2013 to Aug 2018

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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®.

Interventions

  • Tesamorelin for injectionDrug

Arms2

  • Other

    Exposed Group will receive Tesamorelin

  • Other

    Control Group will not receive Tesamorelin

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to development of malignancies in HIV-infected subjects with abdominal lipohypertrophy exposed to EGRIFTA® vs. concurrent, comparable control group not exposed to EGRIFTA®

    Time frame · 10 years

Secondary outcomes(1)

  1. Time to development or worsening of Type 2 Diabetes Mellitus, diabetic retinopathy, hypersensitivity reactions, hepatic and renal function, adverse events and major adverse cardiovascular events

    Time frame · 10 years

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: All of the following inclusion criteria must be fulfilled: 1. Subject has given written informed consent; 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: Exclusion criteria 1 through 4 are based on the contraindications for EGRIFTA®. 1. Disruption of the hypothalamic-pituitary axis, including conditions such as hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma; 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

PepBank is a research reference. Talk to a doctor before you use any peptide.