NCT03536234

Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients

A Prospective, Randomized, Open Study on the Efficacy and Safety of the GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Immune System Regulation AB · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Triptorelin acetate depot	3.75 mg triptorelin depot (monthly injections). 3 doses in total

Timeline

• Start date: 2018-09-19
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2018-05-24
• Last updated: 2021-01-13

Locations

5 sites across 2 countries: Germany, Sweden