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Growth Hormone Therapy for HIV/AIDS
Phase 2
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 48 weeks
Awards & highlights
Study Summary
This trial will study how a drug called recombinant human growth hormone affects the size of the replication competent HIV reservoir in people with HIV on stable antiretroviral therapy. 22 participants will take part for 52 weeks.
Who is the study for?
Adults aged 18-40 with HIV, on stable ART for at least 24 months, undetectable viral load for the past 24 months, and a CD4+ T-cell count ≥350 cells/mm3. Participants must agree to specific contraception methods and cannot have certain health conditions like uncontrolled diabetes or hypertension.Check my eligibility
What is being tested?
The trial is testing if recombinant human growth hormone can reduce the size of HIV reservoirs in patients on ART. It involves administering growth hormone injections for 48 weeks and monitoring its impact on HIV persistence.See study design
What are the potential side effects?
Potential side effects may include changes in blood sugar levels, joint pain such as carpal tunnel syndrome, swelling due to fluid retention (edema), muscle pain, increased risk of developing diabetes or worsening of existing diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the frequency of CD4+ T cells harbouring replication competent HIV (per 106 CD4+ T cells) between baseline (average of 2 assessments at study week -2 and 0) and 48 weeks recombinant human growth hormone administration (study week 48).
Trial Design
1Treatment groups
Experimental Treatment
Group I: Growth HormoneExperimental Treatment1 Intervention
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
450 Previous Clinical Trials
159,864 Total Patients Enrolled
EMD SeronoIndustry Sponsor
143 Previous Clinical Trials
27,179 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy or sensitivity to any ingredients in the study drug.You must use a birth control method that is proven to be highly effective, with a failure rate of less than 1% per year. This contraception method should be used consistently and according to the instructions provided with the product label. Additionally, if you have been taking recombinant human growth hormone, you should continue using contraception for at least 2 weeks after stopping the medication.You have received growth hormone or tesamorelin treatment within the past year.You have a history of pancreatitis, carpal tunnel syndrome (unless it has been treated with surgery), diabetes, angina, heart disease, or any condition that causes moderate to severe swelling.You have used certain medications or substances that affect growth hormones or muscle growth within the past 6 months.You have had or currently have any type of cancer, except for a specific type of skin cancer that is small and not being actively treated.
Research Study Groups:
This trial has the following groups:- Group 1: Growth Hormone
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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