Phase 2 HIV and AIDS Trial, Recruiting NCT06554717 Sponsor: Massachusetts General Hospital Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT06554717
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People between 50 and 80 years old, of any gender
  • People living with HIV who have been on HIV treatment for at least 1 year, with the virus well controlled (very low or undetectable levels in the blood) and a healthy immune cell count
  • People who are not very physically active — specifically, those who report sweating from exercise fewer than 3 days per week and have not done regular strength/resistance training in the past 3 months
  • People who show at least 1 sign of physical frailty, such as weakness, slow walking speed, feeling exhausted, low physical activity, or unintentional weight loss (measured against specific thresholds)
  • People with excess belly fat, measured by waist size, waist-to-hip ratio, or waist-to-height ratio meeting certain thresholds that vary by gender and ethnic background
  • Women aged 74 or under who have had a normal mammogram within the past 2 years, or men aged 70 or under whose prostate-specific antigen (PSA) blood test result is below a certain level — in line with recommended cancer screening guidelines
  • Women who have gone through menopause (no periods for 12 months or more), confirmed by a specific hormone test, or who have had both ovaries surgically removed at least 3 months ago
  • People whose own doctor has approved their participation in the trial

Who may not be able to join:

  • People who have used tesamorelin or other growth hormone-based treatments in the past 6 months
  • People with a certain growth-related hormone (IGF-1) level that is significantly above the normal range for their age
  • People with poorly controlled blood sugar, indicated by an HbA1c blood test result above 8%
  • People with an active or suspected cancer (other than a common type of non-melanoma skin cancer) in the past 2 years
  • People who have recently used high-dose testosterone or steroid medications, or who have had a change in their testosterone or steroid dose in the past 3 months
  • People who have had a change in their diabetes or blood sugar medications (such as a type of medication known as GLP-1 receptor agonists) within the past 3 months
  • People with active or unstable heart disease, chest pain that may be related to the heart, or a serious irregular heartbeat
  • People with a history of conditions affecting the pituitary gland, radiation to the head, or other conditions known to affect growth hormone levels in the body
  • People with a known allergy or sensitivity to tesamorelin or mannitol (an ingredient used in some medications)
  • People with any other acute or ongoing illness that the trial doctor considers unsuitable for participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Lindsay T. Fourman, MD, Massachusetts General Hospital

Phone: 617-643-4590

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
10 July 2025
Est. completion
16 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Repeated Chair Stand Time

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov