Recruiting
Phase 1
Phase 2

Dolutegravir/Rilpivirine

Sponsor:

ViiV Healthcare

Code:

NCT05674656

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Interventions

Dolutegravir/Rilpivirine FDC

Study Details

Brief summary:

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).

Conditions

HIV Infections

Study ID

NCT05674656

Start date

Jul 6, 2023

Status verified date

Sep, 2024

Completion date

May 3, 2028

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Human immuno virus Type-1 (HIV-1) infected child 6 years to less than 12 years of age at the time of signing the informed consent form .
  • Body weight greater than or equal to 25 kilogram (kg) at entry.
  • Confirmed HIV-1-infection
  • Participant has taken the same Antiretroviral therapy (ART) regimen in the 6 months (180 days) prior to Screening, as determined by the site investigator based on participant/parent/guardian report and available medical records.
  • Has a plasma HIV-1 Ribonucleic Acid (RNA) result less than 50 copies/mL at Screening
  • Has at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 6-12 months (180-365 days) prior to Screening OR Has at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected less than 6 months (within 179 days) prior to entry and at least one documented plasma HIV-1 RNA result less than the lower limit of detection of the assay from a specimen collected in the 12-18 months (365-545 days) prior to Screening
  • For participants of reproductive potential (defined as having reached menarche), not pregnant based on testing performed at Screening (i.e., from a specimen collected within 30 days prior to entry) and at Baseline/Day 1.
  • For participants of reproductive potential who are engaging in sexual activity that could lead to pregnancy, willing to use two methods of contraception while receiving study drug and for approximately one month after permanently discontinuing study drug, based on participant/parent/guardian report at entry.
  • For participants of reproductive potential, not breastfeeding based on participant/parent/ guardian report at Baseline/Day 1.

Exclusion Criteria:

  • Documented resistance (ever) to Non-nucleoside reverse transcriptase inhibitors (NNRTIs) or integrase inhibitors
  • Documented HIV-1 RNA result greater than or equal to the lower limit of detection of the assay based on a specimen collected in the 12 months (365 days) prior to Screening
  • Any change (ever) of any Antiretroviral (ARV) agent due to virologic failure, as determined by the site investigator based on participant/parent/guardian report and available medical records
  • Has a history (ever) of allergy to DTG, RPV, or any other component of JULUCA as determined by the site investigator based on participant/parent/guardian report and available medical records.
  • Has a history (ever) of congestive heart failure, symptomatic arrhythmia, or any clinically significant cardiac disease as determined by the site investigator based on participant/ parent/guardian report and available medical records
  • Has a history (ever) of unstable liver disease (defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, or known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) as determined by the site investigator based on participant/parent/guardian report and available medical records
  • Has any of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records: Current clinical evidence of pancreatitis; Currently active AIDS-defining (WHO Clinical Stage 4) opportunistic infection; Currently active TB and/or current rifamycin-containing TB treatment.
  • Has an anticipated need for any HCV therapy during the first 24 weeks of study and for HCV therapy based on interferon or any drugs that have a potential for adverse drug: drug interactions with study treatment throughout the entire study period.
  • Receipt of the following as determined by the site investigator based on participant/ parent/guardian report and available medical records: Any investigational agent within 90 days prior to entry; Any prohibited medication within 30 days prior to entry; Any medication with a known risk of Torsades de Pointes within seven days prior to entry
  • Receipt (ever) of an ART regimen that included both DTG and RPV, as determined by the site investigator based on participant/parent/guardian report and available medical records
  • Any ≥ grade 3 result for the following based on grading per the Division of Acquired Immunodeficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events: Haemoglobin (<8.5 gram per deciliter \[g/dL\] or <5.25 millimoles per liter \[mmol/L\]); Absolute neutrophil count (<600 cells/mm\^3 or <0.600 x 109 cells/L); Platelet count (<50,000cells/mm\^3 or <50.00 x 109 cells/L); Estimated glomerular filtration rate (eGFR: <60ml/min/1.73m\^2); ALT (≥5.0 x Upper limit of Normal \[ULN\]); Aspartate Aminotransferase (AST) (≥5.0 x ULN)
  • Has the following combination of laboratory test results at screening: Alanine transaminase \[ALT\] greater than or equal to 3 x ULN and total bilirubin greater than or equal to 1.5 x ULN and direct bilirubin greater than 35% of total bilirubin
  • Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening.
  • QTc >450 milliseconds (msec) at Screening
  • Severe acute malnutrition (Body Mass Index \[BMI\] for age <-3 or nutritional oedema)
  • Has any documented or suspected clinically significant medical or psychiatric condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
  • The child is a ward of State or government.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dolutegravir(DTG)/Rilpivirine (RPV)

Interventions

Dolutegravir/Rilpivirine FDC

Dolutegravir/Rilpivirine will be administered.

Primary outcome measure

  • Area under the curve (AUC0-24h) of DTG [ Time Frame: Up to Week 24 ]
  • Area under the curve (AUC0-24h) of RPV [ Time Frame: Up to Week 24 ]
  • Number of Participants with Adverse Events (AEs) at Week 24 [ Time Frame: At Week 24 ]
  • Number of Participants with Grade 3 or higher AEs at Week 24 [ Time Frame: At Week 24 ]
  • Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 24 [ Time Frame: At Week 24 ]
  • Number of Participants with Fatal AEs assessed as related to study drug at Week 24 [ Time Frame: At Week 24 ]
  • Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 24 [ Time Frame: 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 [ Time Frame: At Week 24 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Long Beach, California, United States, 90806

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jagmohan Batra

GSK Investigational Site

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Natella Rakhmanina

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33136

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Charles Mitchell

GSK Investigational Site

Recruiting

Tampa, Florida, United States, 33606

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Carina Rodriguez

GSK Investigational Site

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Andres Camacho-Gonzalez

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gloria Heresi

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Susan Gillespie

More Information

Sponsor

ViiV Healthcare

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Keywords

  • Dolutegravir
  • Rilpivirine
  • JULUCA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ViiV Healthcare on 2024-09-19.