HIV-1 infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Gonapeptyl Depot
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: TRIPTORELIN ACETATE
CAS Number: 140194-24-7
Concentration unit: mg milligram(s)
C
Sponsors
Immune System Regulation AB (ISR)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male gender 2. 18 to 65 years of age, inclusive, at the time of informed consent 3. Ability and willingness to give a written informed consent. A signed informed consent must be available prior to any study-related procedures. 4. HIV-1 infection as documented by HIV antibody test 5. CD4+ cell count >300 cells/µL at screening 6. Total HIV-1 DNA level between 100 to 5000 copies/million PBMC as measured by real-time PCR within 4 months prior to screening 7. Plasma HIV-1 RNA level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment failure while on triple ART 2. Nadir CD4+ count 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) 7. Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator 8. Current treatment with testosterone 9. History of any clinically significant kidney disease as determined by the Investigator or eGFR 7.0 mmol/L at screening 11. Intolerance or contraindication to injectable triptorelin 12. Vital signs, physical examination or lab results that exhibit evidence of acute illness 13. Known history of moderate or severe depression (see definitions in ICD-10) within the past 5 years 14. Any congenital or acquired prolongation of the QTc interval and use of any drugs that has been proven to prolong the QTc interval (Normal QTc interval defined as <450 msec) 15. An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician 16. Involvement in any other drug study within 30 days prior to this study entry 17. Any medical condition that in the opinion of the Investigator would compromise the patient’s ability to participate in the study 18. Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements. 19. Condition or concomitant anti-coagulation treatment making intramuscular injections contraindicated (note that treatment with acetylsalicylic acid is permitted). 20. For Germany: Person concerned has been admitted to an institution by virtue of an order issued either by the judicial or the administrative authorities. 21. For Germany: CRO or Sponsor employees or employees under the direct supervision of the Investigator or the investigational sites and/or involved directly in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to evaluate the safety and tolerability of 12 weeks of triptorelin depot treatment in ART treated HIV-1 infected male patients (active group) compared to HIV-1 infected male patients on ART only (control group).;Primary end point(s): The primary efficacy endpoint is the mean change from baseline to week 12 in the levels of total HIV-1 DNA levels in CD4+ cells in the active group compared to the mean change in the control group.;Timepoint(s) of evaluation of this end point: Week 12 assessment versus baseline;Main Objective: The primary objective is to evaluate the efficacy of 12 weeks of triptorelin depot treatment in ART treated HIV-1 infected male patients (active group) compared to HIV-1 infected male patients on ART only (control group). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints are to evaluate the: • 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. • 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. • 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. The following safety parameters will be used to address the safety and tolerability portion of the secondary objectives: • adverse events (AEs) and serious adverse events (SAEs), safety laboratory test results, physical examination findings and vital signs results. ;Timepoint(s) of evaluation of this end point: Efficacy endpoints: week 12 assessment versus baseline Safety endpoints: all timepoints versus baseline | — |
Countries
Germany, Sweden
Contacts
Public ContactAnna Junell
Scandinavian Development Services (SDS)
Outcome results
None listed