Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
An open, randomised, parallel arm phase IIa study. 52 HIV-1 infected patients will be
randomised (in a 1:1 ratio) to either an active group or a control group. The active group
will receive the GnRH analogue triptorelin depot monthly at baseline, week 4 and week 8.
Patients in the active group and in the control group will continue their triple combination
antiretroviral therapy (ART) during the study without changes; unless there is rationale for
change on medical ground. In order to prevent the negative effects of a low testosterone
level, patients in the active group will be offered to receive a single intramuscular depot
injection of testosterone approximately 7 days after triptorelin treatment. This depot
administration will keep the serum testosterone on a normal level until the next triptorelin
dose. This will be repeated when triptorelin is administered at week 4 and week 8. Total
study period is 24 weeks.