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Growth Hormone Releasing Hormone Analog

Tesamorelin for HIV Lipodystrophy Syndrome

Phase 4
Recruiting
Led By Pamela U. Freda, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

Study Summary

This trial will study the effect of tesamorelin, a growth hormone releasing hormone analog, on body composition in patients with HIV lipodystrophy and central adiposity.

Eligible Conditions
  • HIV Lipodystrophy Syndrome
  • Human Growth Hormone Deficiency
  • Body Composition

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hepatic Lipid Content
Secondary outcome measures
Change in Relative gene expression of CD68 gene
Body Weight Changes
Change in Resting Energy Expenditure (REE)
+1 more

Side effects data

From 2008 Phase 3 trial • 263 Patients • NCT00608023
9%
Upper respiratory tract infection
3%
Diarrhoea
3%
Injection site erythema
2%
Paresthesia
1%
Musculosketal stiffness
1%
Chest pain
1%
Retinopathy
1%
Mental status changes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tesamorelin 52 Weeks
Tesamorelin (26 Weeks) - Placebo (26 Weeks)
Placebo (26 Weeks) - Tesamorelin (26 Weeks)

Trial Design

1Treatment groups
Experimental Treatment
Group I: TesamorelinExperimental Treatment1 Intervention
Subjects will be treated with tesamorelin 2 mg by subcutaneous injection daily. Enrolled subjects will have 6 visits - a baseline visit before starting tesamorelin, a visit at 1 month, 3 months, 6 months, 9 months and at 1 year of tesamorelin (GHRH analogue) therapy. Blood sampling for safety labs and clinical examinations will be performed at each visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tesamorelin
FDA approved

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,809 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,217 Total Patients Enrolled
2 Trials studying HIV Lipodystrophy Syndrome
49 Patients Enrolled for HIV Lipodystrophy Syndrome
Pamela U. Freda, MDPrincipal Investigator - Columbia University
Morgan Stanley Children's Hospital, New York Presbyterian Hospital-Columbia Presbyterian Center, New York State Psychiatric Institute
Columbia University College Of Physicians And Surgeons (Medical School)
Ny & Presby Hp-Columbia Campus (Residency)
3 Previous Clinical Trials
422 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Tesamorelin been granted official authorization by the FDA?

"As this is a Phase 4 trial, meaning the treatment has already been approved, our team at Power allocated Tesamorelin a score of 3 on their safety scale."

Answered by AI

Has Tesamorelin been investigated in any prior research projects?

"At this time, there are 4 ongoing studies examining Tesamorelin with none being in the third phase. 8 research locations across the USA are hosting trials for Tesamorelin and a notable number of them can be found near Boston, Massachusetts."

Answered by AI

Does this clinical research encompass those aged 75 and above?

"The requirements for participation in this trial specify that patients must fall between 18 and 68 years of age. Additionally, 23 separate trials are recruiting those under 18, while 28 more clinical studies accept individuals over 65."

Answered by AI

Are there currently any open slots for participation in this research initiative?

"Affirmative. Information on clinicaltrials.gov attests that this research project is actively seeking patients and has been since the 7th of February 2018 - with its details most recently updated on the 24th October 2022. This trial requires enrolment from a single facility, wherein up to 24 people can participate."

Answered by AI

What is the scope of involvement in this medical research?

"Affirmative. According to the clinicaltrials.gov, this medicinal study is currently in search of patients since its initial posting on February 7th 2018 and last update on October 24th 2022. The research requires a total of 24 participants from one medical facility."

Answered by AI

Who is eligible to partake in this medical research initiative?

"This trial seeks to enlist 24 individuals, aged 18-68 and suffering from lipodystrophy. Furthermore, these patients must demonstrate abdominal fat accumulation (102 cm for males and 88 cm for females; 90 cm & 80 cm respectively in East/South Asian populations), have been on a stable weight regimen for the past 8 weeks prior to enrollment, as well as remain on consistent anti-retroviral therapy at time of study entrance."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Body Composition and Adipose Tissue in HIV
Pamela U. Freda 2018. "Body Composition and Adipose Tissue in HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03226821.
~3 spots leftby Apr 2025
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