A randomised, controlled, parallel arm and open study on the efficacy and safety of triptorelin (a GnRH analogue) for HIV-1 reservoir reduction in HIV-1 infected male adult patients on ART medicatio
- Conditions
- HIV-1 infectionTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-004160-35-SE
- Lead Sponsor
- Immune System Regulation AB (ISR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 52
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 or orally witnessed informed consent
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 <50 copies/mL for the last year (one blip allowed; blip defined as HIV RNA between 50-150 copies/mL) including a plasma HIV-1 RNA level <50 copies/mL at screening
8.On triple combination ART (two nucleoside reverse transcriptase inhibitors (NRTI) + one integrase inhibitor or protease inhibitor or one non-NRTI (NNRTI)) for minimum 36 months (assessed at screening)
9.Currently on continuous triple combination ART as specified above (i.e. no changes in medication) the past 4 months prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Treatment failure while on triple ART
2.Nadir CD4+ count < 200 cells/µL
3.History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
4.Known positive result of screening for hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive). Patients treated for HCV and assessed as cured by treating physician is eligible for the study
5.Serious ongoing infection
6.Abnormal liver biochemical tests > 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 < 60 mL/min/1.73 m2 at screening. (Patients on dolutegravir with an eGFR<60 may be verified for study inclusion by analysis of cystatin C that should then be assessed as normal by the Investigator in order for the patient to be eligible)
10.Diabetes mellitus or a fasting plasma blood glucose >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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method