Impact of Recombinant Human Growth Hormone on HIV Persistence
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Antiretroviral therapy (ART) has improved the health of more than 18 million people infected
with HIV by controlling viral replication, AIDS and non-AIDS events, and by reducing the risk
of transmission. However, the existence of latent viral reservoirs in long-lived memory CD4 T
cells remains a hurdle to curing HIV infection; consequently patients must remain on ART for
the rest of their lives. Recently, a more realistic approach under limelight is to identify
strategies leading to a functional cure, which is defined as the natural control of viral
reservoir by the host. Use of recombinant human growth hormone has been shown to improve
immune function by several mechanisms. This study hypothesizes that treatment with
recombinant human growth hormone will decrease the size of the replication competent HIV
reservoir in HIV-infected immune-reconstituted individuals.
The specific study objectives include:
- To evaluate the effect of recombinant human growth hormone administration for 48 weeks
on the size of the replication competent HIV reservoir
- To evaluate the safety and tolerability of recombinant human growth hormone
administration for 48 weeks in HIV-infected individuals on suppressive ART.
For this purpose, the investigators will add recombinant human growth hormone treatment for
the patients receiving stable ART. Approximately 22 participants will be enrolled in this
study at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal,
Canada), which will last about 52 weeks. Participants will be treated with recombinant human
growth hormone for a total of 48 weeks. The initial recombinant human growth hormone dose
will be 3 mg/day (30-40 µg/kg/d) for 24 weeks administered by subcutaneous injection on an
outpatient basis, followed by dose reduction to 1.5 mg/day for the final 24 weeks of the
treatment period, also conducted on an outpatient basis. The study inclusion criteria include
male and female participants, ≥18 and <40 years of age, with an undetectable viral load (the
quantity of the HIV virus in the blood must be less than 50 copies/ml) during last 24 months
and with a CD4 T-cell count ≥350 cells/mm3 obtained within 30 days prior to study entry. The
findings from this study will contribute to the development of novel strategies to eradicate
HIV.
Phase:
Phase 2
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre