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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 48 weeks 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 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor

443 Previous Clinical Trials

159,476 Total Patients Enrolled

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,179 Total Patients Enrolled

Media Library

Growth Hormone Clinical Trial Eligibility Overview. Trial Name: NCT03091374 — Phase 2

HIV/AIDS Research Study Groups: Growth Hormone

HIV/AIDS Clinical Trial 2023: Growth Hormone Highlights & Side Effects. Trial Name: NCT03091374 — Phase 2

Growth Hormone 2023 Treatment Timeline for Medical Study. Trial Name: NCT03091374 — Phase 2

Frequently Asked Questions

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

Who has been approved to participate in this experiment?

"A total of 22 participants are being sought out for this medical trial, which requires its enrollees to have HIV/AIDS and be within the 18-40 age range."

Answered by AI

To what disorders does Growth Hormone provide therapeutic benefits?

"Growth Hormone is a viable treatment for general surgery, people with short stature, and those suffering from open epiphyses."

Answered by AI

Is Growth Hormone a viable option for individuals to consider in terms of safety?

"Growth Hormone is considered a relatively safe intervention as evidenced by its score of 2 on our scale. This is due to there being some evidence supporting safety, but no data yet demonstrating efficacy."

Answered by AI

Has enrollment for this trial opened up yet?

"This clinical trial is now closed for enrollment. It was initially published on December 1st, 2016 and its last edit occured on March 13th, 2021. Fortunately, there are still 615 studies recruiting HIV/AIDS patients and 32 trials seeking additional growth hormone participants."

Answered by AI

How many participants is the upper limit of this research endeavor?

"This research project has already filled its quota of participants and is no longer taking applications. It was initially advertised on December 1st, 2016 and last updated March 13th, 2023. If you are in the market for alternative clinical trials there are 615 studies concerning HIV/AIDS that have open enrolment slots and 32 Growth Hormone related projects seeking patients."

Answered by AI

Is the age of eligibility for this trial exceeding 25 years?

"This clinical trial requires that potential participants be aged between 18 and 40."

Answered by AI

Has this type of clinical trial been conducted previously?

"Presently, 32 clinical trials involving Growth Hormone are being conducted in 169 cities and 44 nations. BioPartners GmbH initiated the inaugural trial for this medication in 2005 which involved 144 patients and culminated with Phase 3 approval. Since then, 210 such experiments have been concluded."

Answered by AI

Have past investigations centered around Growth Hormone yielded positive results?

"At the moment, 32 medical trials are ongoing into Growth Hormone. 12 of these live studies have reached Phase 3 status and a majority of them are taking place in Philadelphia, Pennsylvania. However, there is an expansive network of 642 study locations that span across the country undertaking research regarding this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Recombinant Human Growth Hormone on HIV Persistence

Jean-Pierre Routy 2016. "Impact of Recombinant Human Growth Hormone on HIV Persistence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03091374.

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