HIV-1-infectionPhase 2NCT03536234
Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients
A Phase 2 study testing Triptorelin acetate depot in people with HIV-1-infection, run by Immune System Regulation AB at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Triptorelin acetate depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Sep 2018to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender
- 18 to 65 years of age, inclusive, at the time of informed consent
- Ability and willingness to give a written or orally witnessed informed consent
- HIV-1 infection as documented by HIV antibody test
- CD4+ cell count >300 cells/μL at screening
- Total HIV-1 DNA level between 100 to 5000 copies/million PBMC as measured by real-time PCR within 4 months prior to screening
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- 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
- 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)
- Currently on continuous triple combination ART as specified above (i.e. no changes in medication) the past 4 months prior to screening
Who cannot join
- Treatment failure while on triple ART
- Nadir CD4+ count < 200 cells/μL
- History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
- 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
- Serious ongoing infection
- Abnormal liver biochemical tests > 2 x upper limit of normal (ULN) of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP)
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- Total testosterone, LH or FSH levels at screening assessed as clinically abnormal by the Investigator
- Current treatment with testosterone
- 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)
- Diabetes mellitus or a fasting plasma blood glucose >7.0 mmol/L at screening
- Intolerance or contraindication to injectable triptorelin
- Vital signs, physical examination or lab results that exhibit evidence of acute illness
- Known history of moderate or severe depression (see definitions in ICD-10) within the past 5 years
- 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)
- Involvement in any other drug study within 30 days prior to this study entry
- An increased PSA (Prostate Specific Antigen) value that is assessed as abnormal by the treating physician
- Any medical condition that in the opinion of the Investigator would compromise the patient's ability to participate in the study
- Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden3 sites, 3 recruiting
- Recruiting
Östra sjukhuset
Gothenburg, 416 50
Piotr Nowak, MD PhD, Piotr.Nowak@ki.se
- Recruiting
Södersjukhuset
Stockholm, 118 83
Piotr Nowak, MD PhD, Piotr.Nowak@ki.se
- Recruiting
Karolinska University Hospital Huddinge
Stockholm, 141 86
Piotr Nowak, MD PhD, Piotr.Nowak@ki.se
Germany2 sites, 2 recruiting
- Recruiting
Zentrum für Infektiologie Berlin Prenzlauer Berg
Berlin, 10439
Jukka Hartikainen, MD, hartikainen@zibp.de
- Recruiting
MVZ Karlsplatz
Munich, 80335
Jukka Hartikainen, MD, hartikainen@zibp.de
About this study
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
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.
- Conditions
- HIV-1-infection
- Being tested
- Triptorelin acetate depot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin acetate depotDrug
3.75 mg triptorelin depot (monthly injections). 3 doses in total
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin (GnRH analogue) | Experimental | Not described Receives: Drug: Triptorelin acetate depot |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks time point
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline to 12 weeks time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start19 Sep 2018
- Primary completionAug 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immune System Regulation AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ola Winqvist, MD, PhD, Study director, ISR AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536234
- Sponsor's protocol ID
- ISR-003
- Status last verified
- Jan 2021
- First submitted
- 20 Apr 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03536234
- Acronym / sponsor ID
- ISR-003
- Conditions
- HIV-1-infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Immune System Regulation ABIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin (GnRH analogue) | Experimental | Drug: Triptorelin acetate depot |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male gender
- 18 to 65 years of age, inclusive, at the time of informed consent
- Ability and willingness to give a written or orally witnessed informed consent
- HIV-1 infection as documented by HIV antibody test
- CD4+ cell count >300 cells/μL at screening
Key exclusion criteria (18 listed)
- Treatment failure while on triple ART
- Nadir CD4+ count < 200 cells/μL
- History of any immunodeficiency disease or condition other than HIV, chronic clinically significant illness or autoimmune disease
- 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
- Serious ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin acetate depot3.75 mg triptorelin depot (monthly injections). 3 doses in total | Drug | Triptorelin (GnRH analogue) |
Primary outcome
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
5 secondary outcomes
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
Time frame: Baseline to 12 weeks time point
Number and percentage of patients reporting any adverse events in active group compared to control group
Time frame: Baseline to 12 weeks time point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Winqvist, MD, PhD study director
ISR AB
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Triptorelin acetate depot in people with HIV-1-infection, run by Immune System Regulation AB at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ola Winqvist, MD, PhD (+46-70-5427939, ola.winqvist@israb.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.