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

What Was Tested

In this phase 2 trial, researchers set out to test Triptorelin.

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.

It had two arms (groups): Triptorelin (GnRH analogue) (experimental) and Control group (no intervention).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 52 planned participants were the target.

It was open to men only aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 18 exclusion criteria; among the exclusions: treatment failure while on triple art; nadir cd4+ count \< 200 cells/μl; serious ongoing infection.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-09-19 with completion listed for 2021-08.

It ran at 5 sites in Sweden (3) and Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (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).

It also tracked 5 secondary outcomes, for example 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, Number of adverse events in active group compared to control group and Number and percentage of patients reporting any adverse events in active group compared to control group.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 52 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.