About the study (objectives)
The persistent, dormant HIV that hides in some CD4+ T cells (immune cells) make up what is called the viral reservoir. These viruses maintain their ability to replicate if antiretroviral therapy (ART) is stopped. Aside from necessitating life-long ART adherence, the viral reservoir also contributes to a state of chronic inflammation and immune activation that can contribute to a wide variety of health complications. CTN 298 will assess the ability of human growth hormone (HGH) to increase production of new CD4+ T cells and reduce the size of the viral reservoir.
About the disease/condition (background/context)
New immune cells that have not come in contact with HIV, called naïve CD4+ T cells, are rarely infected by HIV in people who are virally suppressed. This means that increasing the number of naïve cells could reduce the size of the viral reservoir. HGH, a naturally occurring hormone, may increase production of naïve cells in the thymus, an organ of the immune system located in the chest.
Study Approach (methodology)
This study will last about 24 months and will include 22 participants. Participants will inject themselves with HGH at bedtime, daily, for 48 weeks; the dose in the first 24 weeks of the study will be 3 mg/day and reduced to 1.5 mg/day in the latter 24 weeks. Results of blood draws and lab tests will be compared between the baseline visit, the initiation of HGH dose, and 12, 24, 36, and 48 weeks post-initiation. Participants will also attend a safety follow-up visit at 52 weeks post-initiation. The primary objective is to compare the size of the viral reservoir with secondary measurements of HIV persistence, CD4+ T cells, and HGH safety and tolerability.
- HIV-1 positive male or female between 18 and 40 years of age
- Currently on continuous ART for at least 24 months with no change in regimen in 12 weeks prior to beginning the study
- CD4+ T-cell count ≥350 cells/mm3obtained within 30 days prior to study
- Undetectable viral load for at least 24 months prior to study entry and confirmed within 60 days prior to study
- For female participants, negative pregnancy test and agreement to follow contraceptive methods to avoid pregnancy during the study (see full details at gov)
- Able to understand and sign the informed consent form prior to screening
- Individuals who are suffering from severe systemic diseases (uncontrolled hypertension, chronic renal failure), or active uncontrolled infections
- Individuals having diabetes mellitus or hypertension
- Active or past history of malignancy
- Acute or serious illness requiring hospitalization within 90 days prior to entering the study
- Receipt of antibiotics or vaccination within 30 days of starting the study or expected vaccination after screening but before baseline visit.
- 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
- 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
For full eligibility and to learn more about this study, please refer to clinicaltrials.gov.
Chronic Viral Illness Service
Royal Victoria Hospital
McGill University Health Centre (MUHC)
1001 Decarie Blvd., Room D02.4017
Montreal, Quebec, H4A 3J1
If you would like more information on this clinical study, please contact the principal investigator. This study received funding from EMD Serono, Inc. (Rockland, MA).