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

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ClinicalTrials.gov Identifier: NCT03536234
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Immune System Regulation AB

Brief 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.

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Triptorelin acetate depot Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Triptorelin (GnRH analogue) Drug: Triptorelin acetate depot
3.75 mg triptorelin depot (monthly injections). 3 doses in total

No Intervention: Control group



Primary Outcome Measures :
  1. Mean 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Number of adverse events in active group compared to control group [ Time Frame: Baseline to 12 weeks time point ]
    Adverse events will be presented by Medical Dictionary for Regulatory Activities MedDRA) preferred term (PT) and system organ class (SOC).

  5. Number and percentage of patients reporting any adverse events in active group compared to control group [ Time Frame: Baseline to 12 weeks time point ]
    Number and percentage of patients reporting any adverse event will be be presented by MedDRA PT and SOC.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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 500 to 5000 copies/million PBMC as measured by real-time PCR at screening
  7. Plasma HIV-1 RNA level <20 copies/mL for the last year (one blip allowed) including a plasma HIV-1 RNA level <20 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

Exclusion Criteria:

  1. Treatment failure while on triple ART
  2. More than one blip with 20 to 150 copies RNA/mL in the year preceding screening
  3. Nadir CD4+ count < 200 cells/μL
  4. History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
  5. Any positive result of screening for hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive or HCV antigen positive)
  6. Acute or serious ongoing infection
  7. Abnormal liver biochemical tests > 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP)
  8. Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator
  9. Current treatment with testosterone
  10. History of any clinically significant kidney disease as determined by the Investigator or eGFR < 60 mL/min/1.73 m2 at screening
  11. Diabetes mellitus or a fasting plasma blood glucose >7.0 mmol/L at screening
  12. Intolerance or contraindication to injectable triptorelin
  13. Vital signs, physical examination or lab results that exhibit evidence of acute illness
  14. Known history of moderate or severe depression within the past 5 years
  15. 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 <430 msec)
  16. Involvement in any other drug study within 30 days prior to this study entry
  17. An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician
  18. Any medical condition that in the opinion of the Investigator would compromise the patient's ability to participate in the study
  19. Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536234


Contacts
Contact: Ola Winqvist, MD, PhD +46-70-5427939 ola.winqvist@israb.se

Locations
Sweden
Södersjukhuset Recruiting
Stockholm, Sweden, 118 83
Contact: Piotr Nowak, MD PhD       Piotr.Nowak@ki.se   
Karolinska University Hospital Huddinge Recruiting
Stockholm, Sweden, 141 86
Contact: Piotr Nowak, MD PhD       Piotr.Nowak@ki.se   
Sponsors and Collaborators
Immune System Regulation AB
Investigators
Study Director: Ola Winqvist, MD, PhD ISR AB

Responsible Party: Immune System Regulation AB
ClinicalTrials.gov Identifier: NCT03536234     History of Changes
Other Study ID Numbers: ISR-003
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents