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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin (GnRH analogue) | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin acetate depot | Drug | 3.75 mg triptorelin depot (monthly injections). 3 doses in total |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks time point |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ola Winqvist, MD, PhD | Contact | +46-70-5427939 | ola.winqvist@israb.se |
| Name | Affiliation | Role |
|---|---|---|
| Ola Winqvist, MD, PhD | ISR AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Infektiologie Berlin Prenzlauer Berg | Recruiting | Berlin | 10439 | Germany |
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| 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. | 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). | 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. | Baseline to 12 weeks time point |
| MVZ Karlsplatz | Recruiting | Munich | 80335 | Germany |
|
| Östra sjukhuset | Recruiting | Gothenburg | 416 50 | Sweden |
|
| Södersjukhuset | Recruiting | Stockholm | 118 83 | Sweden |
|
| Karolinska University Hospital Huddinge | Recruiting | Stockholm | 141 86 | Sweden |
|