RECRUITING

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Conditions

HIV Infections Dolutegravir Rilpivirine JULUCA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1

Quick Facts

Study Start:2023-07-06

Study Completion:2028-05-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05674656

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

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

Principal Investigator

GSK Clinical Trials

STUDY_DIRECTOR

ViiV Healthcare

Study Locations (Sites)

GSK Investigational Site

Long Beach, California, 90806

United States

GSK Investigational Site

Washington, District of Columbia, 20010

United States

GSK Investigational Site

Fort Lauderdale, Florida, 33316

United States

GSK Investigational Site

Miami, Florida, 33136

United States

GSK Investigational Site

Tampa, Florida, 33606

United States

GSK Investigational Site

Atlanta, Georgia, 30322

United States

GSK Investigational Site

Houston, Texas, 77030

United States

GSK Investigational Site

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: ViiV Healthcare

GSK Clinical Trials, STUDY_DIRECTOR, ViiV Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-06

Study Completion Date2028-05-03

Study Record Updates

Study Start Date2023-07-06

Study Completion Date2028-05-03

Terms related to this study

Keywords Provided by Researchers

Dolutegravir
Rilpivirine
JULUCA

Additional Relevant MeSH Terms

HIV Infections