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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
3.75 mg triptorelin depot (monthly injections). 3 doses in total
Zentrum für Infektiologie Berlin Prenzlauer Berg
Berlin, Germany
RECRUITINGMVZ Karlsplatz
Munich, Germany
RECRUITINGÖstra sjukhuset
Gothenburg, Sweden
RECRUITINGSödersjukhuset
Stockholm, Sweden
RECRUITINGKarolinska University Hospital Huddinge
Stockholm, Sweden
RECRUITINGMean change from baseline to week 12 in total HIV-1 DNA levels in CD4+ cells in the active group compared to the mean change in the control group.
Time frame: Baseline to 12 weeks time point
Mean change of the HLA class 1 expression from baseline to week 12 in the active group compared to the mean change in the control group
Time frame: Baseline to 12 weeks time point
Mean change in the CD4+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.
Time frame: Baseline to 12 weeks time point
Mean change in the CD8+ T-cell counts from baseline to week 12 in the active group compared to the mean change in the control group.
Time frame: Baseline to 12 weeks time point
Number of adverse events in active group compared to control group
Adverse events will be presented by Medical Dictionary for Regulatory Activities MedDRA) preferred term (PT) and system organ class (SOC).
Time frame: Baseline to 12 weeks time point
Number and percentage of patients reporting any adverse events in active group compared to control group
Number and percentage of patients reporting any adverse event will be be presented by MedDRA PT and SOC.
Time frame: Baseline to 12 weeks time point
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.