Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

September 13, 2024 updated by: ViiV Healthcare

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jagmohan Batra
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natella Rakhmanina
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Completed
        • GSK Investigational Site
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Mitchell
      • Tampa, Florida, United States, 33606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carina Rodriguez
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andres Camacho-Gonzalez
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susan Gillespie

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dolutegravir(DTG)/Rilpivirine (RPV)
Drug: Dolutegravir/Rilpivirine FDC
Dolutegravir/Rilpivirine will be administered.
Other Names:
  • JULUCA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the curve (AUC0-24h) of DTG
Time Frame: Up to Week 24
Up to Week 24
Area under the curve (AUC0-24h) of RPV
Time Frame: Up to Week 24
Up to Week 24
Number of Participants with Adverse Events (AEs) at Week 24
Time Frame: At Week 24
At Week 24
Number of Participants with Grade 3 or higher AEs at Week 24
Time Frame: At Week 24
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
At Week 24
Number of Participants with Fatal AEs assessed as related to study drug at Week 24
Time Frame: At Week 24
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
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
At Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL)
Time Frame: At Week 24 and 48
At Week 24 and 48
Cluster of differentiation 4 (CD4+) Cell Count
Time Frame: At Week 24 and 48
At Week 24 and 48
Percentage of CD4+ Cell Count
Time Frame: At Week 24 and 48
At Week 24 and 48
Number of Participants with Adverse Events (AEs) at Week 48
Time Frame: At Week 48
At Week 48
Number of Participants with Grade 3 or higher AEs at Week 48
Time Frame: At Week 48
At Week 48
Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 48
Time Frame: At Week 48
At Week 48
Number of Participants with Fatal AEs assessed as related to study drug at Week 48
Time Frame: At Week 48
At Week 48
Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 48
Time Frame: 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
Time Frame: At Week 48
At Week 48
Minimum drug concentration (Cmin) of DTG
Time Frame: Up to Week 24
Up to Week 24
Cmin of RPV
Time Frame: Up to Week 24
Up to Week 24
Cmin of DTG at Week 4 Visit
Time Frame: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Cmin of RPV at Week 4 Visit
Time Frame: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Concentration of HIV-1 RNA
Time Frame: Baseline (Day 1), Week 4, 8, 12, 16, 20, 24, 36 and 48
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)
Time Frame: Baseline (Day 1) and up to Week 48
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)
Time Frame: Up to Week 48
Up to Week 48
Number of Participants with HIV-1 genotypes at Baseline, Week 24 and 48
Time Frame: Baseline (Day 1), Week 24 and 48
Baseline (Day 1), Week 24 and 48
Number of Participants with Acceptability to JULUCA
Time Frame: At Week 4, 24 and 48
At Week 4, 24 and 48
Number of Participants with Adherence to JULUCA
Time Frame: At Week 4, 24 and 48
At Week 4, 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: GSK Clinical Trials, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205868
  • 2022-000829-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Dolutegravir/Rilpivirine FDC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings