Loading clinical trials...

UNKNOWNPHASE2

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

NCT03536234•Immune System Regulation AB

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

MALE

Healthy Volunteers

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 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

Exclusion Criteria

•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). Patient 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
+8 more criteria

Locations (5)

Zentrum für Infektiologie Berlin Prenzlauer Berg

Berlin, Germany

MVZ Karlsplatz

Munich, Germany

Östra sjukhuset

Gothenburg, Sweden

Södersjukhuset

Stockholm, Sweden

Karolinska University Hospital Huddinge

Stockholm, Sweden

Key Dates

Start Date

September 19, 2018

Primary Completion Date

August 1, 2021

Completion Date

December 1, 2021

Last Updated

January 13, 2021

Enrollment

ESTIMATED participants

Conditions

HIV-1-infection

Interventions

Triptorelin acetate depot

DRUG

Contacts

Ola Winqvist, MD, PhD

CONTACT

+46-70-5427939 ola.winqvist@israb.se

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

View study

RECRUITINGNA

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

DepressionHIV-1-infection+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

Administration of Venetoclax to Promote Apoptosis of HIV-infected Cells and Reduce the Size of the HIV Reservoir Among People Living With HIV on ART

Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

Caspofungin for Pneumocystis Pneumonia in PLWHIV.

PrEPsmart 2-1-1 Pilot