Growth hormone shows promise in shrinking HIV's hiding spots
NCT ID NCT03091374
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether giving recombinant human growth hormone for 48 weeks could reduce the hidden HIV reservoir in people already on successful antiretroviral therapy (ART). The goal was to move toward a 'functional cure' where the body can control the virus without lifelong medication. Twenty-two HIV-positive adults with undetectable viral loads took part. The main focus was on safety and measuring changes in the size of the viral reservoir.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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22 people
The number who actually took part.
- Started
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Dec 2016
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * HIV-1 infected male or female adults aged ≥18 and \<40 years * Able to provide written consent * Currently on continuous ART for at least 24 months with no change in regimen in 12 weeks prior to study entry. Some modifications of ART doses during the 12 weeks prior to study entry are permitted. In addition, the change in formulation (e.g., from standard formulation to fixed-dose combination) is allowed within 12 weeks prior to study entry. A within class single drug substitution (e.g., switch from tenofovir to abacavir or raltegravir to dolutegravir) is allowed within 12 weeks prior to study entry * CD4+ T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. * HIV-1 RNA level below the limit of quantification using an FDA-approved assay for at least 24 months prior to study entry and confirmed within 60 days prior to study entry. Single determinations that are between the assay quantification limit and 200 copies/mL are allowed as long as the preceding and subsequent determinations are below the level of quantification * Female participants, may be eligible to enter and participate in the study if they are: of non-child-bearing potential (defined as physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy), or of child- bearing potential with a negative pregnancy test at both Screening and Day 1 and agree to use one of the following methods of contraception to avoid pregnancy: 1. Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications 2. Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); barrier methods must be in use at least 14 days prior to study drug administration 3. Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion. IUD must be in use at least 30 days prior to first study drug administration 4. Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject; the vasectomy must be completed 3 months prior to first study drug administration or in the alternative that a 0 sperm count will suffice 5. Approved hormonal contraception 6. Any other method with published data showing that the expected failure rate is \<1% per year Note: Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of recombinant human growth hormone. Exclusion Criteria: * Fasting glucose ≥100 mg/dL * Hemoglobin A1c ≥ 5.7% * ALT \[serum glutamic pyruvic transaminase (SGPT)\] \> 2 times upper limit of normal (ULN) * AST \[serum glutamic oxaloacetic transaminase (SGOT)\] \> 2 x ULN * Estimated creatinine clearance ≤ 50 mL/min by Cockcroft-Gault * Hemoglobin \< 11.5 g/dL * Platelets \<100,000/mm3 * ANC \< 1000/mm3 * Any active or past history of malignancy, except for localized cutaneous Kaposi's sarcoma (fewer than 10 lesions, none of which are larger than 2 cm, and not on active therapy) * Prior therapy with growth hormone or tesamorelin during 12 months preceding screening visit * Unstable or untreated hypertension, defined as ≥ 160/90 mm Hg at the time of the screening visit * History of pancreatitis, carpal tunnel syndrome (unless resolved by surgical release), diabetes mellitus, angina pectoris, coronary artery disease, or any disorder associated with moderate to severe edema (e.g. ascites, nephrotic syndrome, congestive heart failure, lymphedema) * Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry * Receipt of antibiotic therapy within 30 days prior to study entry * Chronic hepatitis C infection defined as a positive hepatitis C antibody and positive hepatitis C RNA at any time prior to study entry. Subjects who are positive for hepatitis C antibody but who are HCV RNA negative are permitted in the study * Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry or during study * Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation * Recent vaccination within 30 days prior to study entry or expected vaccination after screening but before baseline visit * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Receive testosterone therapy for hypogonadism unless prior testosterone deficiency is documented * Change in regimen or supraphysiological dose of testosterone in men (measured by elevated free testosterone above normal levels) within 2 months prior to screening * Use of anabolic steroids, GH, GH secretagogue, GHRF products or analogs, IGF-1, or IGF binding protein 3 (IGFBP 3) within 6 months prior to screening * Women who are lactating
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mcgill University Health Center
Montreal, Quebec, H4A 3J1, Canada
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Other studies related to the condition(s) this trial covers.
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