Vaccines and Immunotherapies (VIT)
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.
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.
This study will last about 24 months and will include 10 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.
Required for the initial screening component of the study:
For full eligibility and to learn more about this study, please refer to clinicaltrials.gov.
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).