Body Composition and Adipose Tissue in HIV (NCT03226821) | Clinical Trial Compass
TerminatedPhase 4
Body Composition and Adipose Tissue in HIV
Stopped: lack of availability of the study drug
United States6 participantsStarted 2018-02-07
Plain-language summary
In this study, the investigators will examine the effect of therapy with the Growth Hormone Releasing Hormone (GHRH) analog tesamorelin on body composition in patients with HIV lipodystrophy and central adiposity. This study is a single arm prospective study of tesamorelin therapy of patients with HIV lipodystrophy. Subjects will do body composition testing, adipose tissue biopsy, metabolic rate measurements and insulin sensitivity assessment before, 6 and 12 months after daily injections of tesamorelin 2 mg by subcutaneous injection.
Who can participate
Age range
18 Years – 68 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV-infected subjects with HIV lipodystrophy (HIVLD)
* Abdominal fat accumulation defined as: Waist Circumference (WC) 102 cm for men, 88 cm for women, except in subjects of East/South Asian ethnicity in whom this will be defined by WC 90 cm for men and 80 cm for women.
* Weight stable for 8 weeks prior to enrollment,
* CD4 count \>100 cells/mm3
* HIV RNA load \<1000 copies/mL
* Fasting plasma glucose \<120 mg/dL
* Stable combination anti-retroviral therapy (cART) of any regimen for ≥ 8 weeks prior to study enrollment
Exclusion Criteria:
* Diabetes mellitus requiring medication
* History of any malignancy
* Abnormal renal or liver function
* Pregnancy or women of childbearing age who are not using an acceptable means of contraception
* History disorder of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery
* Head irradiation or head trauma or adrenal insufficiency
* Systemic glucocorticoid use
* Known hypersensitivity to tesamorelin and/or mannitol
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.