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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000829-24 | EudraCT Number |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir(DTG)/Rilpivirine (RPV) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir/Rilpivirine FDC | Drug | Dolutegravir/Rilpivirine will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC0-24h) of DTG | Up to Week 24 | |
| Area under the curve (AUC0-24h) of RPV | Up to Week 24 | |
| Number of Participants with Adverse Events (AEs) at Week 24 | At Week 24 | |
| Number of Participants with Grade 3 or higher AEs at Week 24 | At Week 24 | |
| Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 24 | At Week 24 | |
| Number of Participants with Fatal AEs assessed as related to study drug at Week 24 | At Week 24 | |
| Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 24 | At Week 24 | |
| Number of Participants with AEs assessed as related to study drug that led to permanent discontinuation of study drug at Week 24 | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL) | At Week 24 and 48 | |
| Cluster of differentiation 4 (CD4+) Cell Count | At Week 24 and 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | ViiV Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Long Beach | California | 90806 | United States |
Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
| C000629908 | dolutegravir, rilpivirine drug combination |
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| Percentage of CD4+ Cell Count |
| At Week 24 and 48 |
| Number of Participants with Adverse Events (AEs) at Week 48 | At Week 48 |
| Number of Participants with Grade 3 or higher AEs at Week 48 | At Week 48 |
| Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 48 | At Week 48 |
| Number of Participants with Fatal AEs assessed as related to study drug at Week 48 | At Week 48 |
| Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 48 | At Week 48 |
| Number of Participants with AEs assessed as related to study drug that led to permanent discontinuation of study drug at Week 48 | At Week 48 |
| Minimum drug concentration (Cmin) of DTG | Up to Week 24 |
| Cmin of RPV | Up to Week 24 |
| Cmin of DTG at Week 4 Visit | Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4 |
| Cmin of RPV at Week 4 Visit | Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4 |
| Concentration of HIV-1 RNA | Baseline (Day 1), Week 4, 8, 12, 16, 20, 24, 36 and 48 |
| Number of Participants with HIV-1 Genotype at the time of Virologic failure (HIV-1 RNA greater than or equal to 200 copies/mL) | Baseline (Day 1) and up to Week 48 |
| Number of Participants with HIV-1 Phenotype at the time of Virologic failure (HIV-1 RNA greater than or equal to 200 copies/mL) | Up to Week 48 |
| Number of Participants with HIV-1 genotypes at Baseline, Week 24 and 48 | Baseline (Day 1), Week 24 and 48 |
| Number of Participants with Acceptability to JULUCA | At Week 4, 24 and 48 |
| Number of Participants with Adherence to JULUCA | At Week 4, 24 and 48 |
| GSK Investigational Site | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| GSK Investigational Site | Completed | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Recruiting | Miami | Florida | 33136 | United States |
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| GSK Investigational Site | Recruiting | Tampa | Florida | 33606 | United States |
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| GSK Investigational Site | Recruiting | Atlanta | Georgia | 30322 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| GSK Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
|
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |