HIV-1-infection study: Tesamorelin vs Exercise
Official title Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
ClinicalTrials.gov ID: NCT06554717
What this study is testing
What is Tesamorelin?
This is an investigational injectable medicine being studied to see if it can improve physical function and muscle health in adults with HIV. It is designed to act like a natural hormone in the body that signals the release of growth hormone.
Also referred to as Egrifta.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if adding the medication tesamorelin to an exercise program helps improve physical function and muscle health in people with HIV.
- Who it's for
- The study is looking for adults living with HIV who have reduced physical function or frailty.
- What's involved
- Participants will take either tesamorelin or a placebo for 24 weeks while following a home-based exercise plan supervised by a coach. They will undergo tests to measure muscle mass, strength, and quality of life.
- Time commitment
- The study lasts 48 weeks, involving a 24-week treatment phase followed by a 24-week monitoring period without the study drug.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Men and women, 50-80 years old
- Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA \ 200/µL 3
- Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \<3 days/week with no regular resistance exercise in the past 3...
- ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific...
- Excess abdominal adiposity as indicated by at least one of the following elevated anthropometric measures assessed at Screen: (1) waist circumference...
You likely can't join if
- Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- Insulin-like growth factor 1 (IGF-1) z-score \>2.0
- HbA1c \>8%
- Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
- Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
- Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
See the full eligibility criteria
- Men and women, 50-80 years old
- Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA \ 200/µL 3
- Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \<3 days/week with no regular resistance exercise in the past 3 months
- ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)
- Excess abdominal adiposity as indicated by at least one of the following elevated anthropometric measures assessed at Screen: (1) waist circumference ≥102 cm in non-Asian males (≥90 cm in Asian males) or ≥88 cm in...
- Normal mammogram within 2 years (females ≤74 years old) or prostate specific antigen \<4 ng/mL (males ≤70 years old) per U.S. Preventive Services Task Force (USPSTF) age-appropriate cancer screening guidelines
- For females, postmenopausal defined as no menses for ≥12 months and anti-müllerian hormone (AMH) \<20 pg/mL or history of bilateral oophorectomy at least 3 months ago
- Provider approval to participate
- Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- Insulin-like growth factor 1 (IGF-1) z-score \>2.0
- HbA1c \>8%
- Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
- Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
- Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
- Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia
- History of hypopituitarism, head irradiation, or other conditions known to affect the GH/IGF-1 axis
- Known hypersensitivity to tesamorelin or mannitol
- Acute or chronic illness judged by the investigator to represent a contraindication to study participation
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.