Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

DolutegravirRilpivirineJULUCA

Outcome Measures

Primary Outcomes (8)

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

Secondary Outcomes (19)

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
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
+14 more secondary outcomes

Study Arms (1)

Dolutegravir(DTG)/Rilpivirine (RPV)

EXPERIMENTAL

Drug: Dolutegravir/Rilpivirine FDC

Interventions

Dolutegravir/Rilpivirine FDCDrug

Dolutegravir/Rilpivirine will be administered.

Also known as: JULUCA

Dolutegravir(DTG)/Rilpivirine (RPV)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Dolutegravir/Rilpivirine FDC
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age6 Years - 12 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

Sponsors & Collaborators

Janssen Research & Development, LLC
Industrycollaborator
ViiV Healthcare
Industrylead

Study Sites (8)

GSK Investigational Site

Long Beach, California, 90806, United States

RECRUITING

US GSK Clinical Trials Call CenterCONTACT877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call CentreCONTACT+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Jagmohan BatraPRINCIPAL INVESTIGATOR

GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

MeSH Terms

Conditions

HIV Infections

Interventions

dolutegravirdolutegravir, rilpivirine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital Diseases

Study Officials

GSK Clinical Trials
ViiV Healthcare
STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

January 6, 2023

Study Start

July 6, 2023

Actual (reported)

Primary Completion

June 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

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)
+2 more criteria

Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (19)

Study Arms (1)

Dolutegravir(DTG)/Rilpivirine (RPV)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (19)

Study Arms (1)

Dolutegravir(DTG)/Rilpivirine (RPV)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations