HIV InfectionsPhase 1/2NCT05674656
Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
A Phase 1/2 study testing Dolutegravir/Rilpivirine FDC in people with HIV Infections, run by ViiV Healthcare at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dolutegravir/Rilpivirine FDC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Jul 2023to 3 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 7 recruiting
- Recruiting
GSK Investigational Site
Atlanta, Georgia, 30322
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Completed
GSK Investigational Site
Fort Lauderdale, Florida, 33316
- Recruiting
GSK Investigational Site
Houston, Texas, 77030
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Houston, Texas, 77030
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Long Beach, California, 90806
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Miami, Florida, 33136
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tampa, Florida, 33606
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Washington D.C., District of Columbia, 20010
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
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
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
- Being tested
- Dolutegravir/Rilpivirine FDC
- Keywords
- Dolutegravir, Rilpivirine, JULUCA
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir/Rilpivirine FDCDrug
Also called JULUCA
Dolutegravir/Rilpivirine will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Dolutegravir(DTG)/Rilpivirine (RPV) | Experimental | Not described Receives: Drug: Dolutegravir/Rilpivirine FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC0-24h) of DTG
Measured: Up to Week 24
Area under the curve (AUC0-24h) of RPV
Measured: Up to Week 24
Number of Participants with Adverse Events (AEs) at Week 24
Measured: At Week 24
Number of Participants with Grade 3 or higher AEs at Week 24
Measured: At Week 24
Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 24
Measured: At Week 24
Number of Participants with Fatal AEs assessed as related to study drug at Week 24
Measured: At Week 24
Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 24
Measured: 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
Measured: At Week 24
Secondary outcomes (19)
Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL)
Measured: At Week 24 and 48
Cluster of differentiation 4 (CD4+) Cell Count
Measured: At Week 24 and 48
Percentage of CD4+ Cell Count
Measured: At Week 24 and 48
Number of Participants with Adverse Events (AEs) at Week 48
Measured: At Week 48
Number of Participants with Grade 3 or higher AEs at Week 48
Measured: At Week 48
Number of Participants with Grade 3 or higher AEs assessed as related to study drug at Week 48
Measured: At Week 48
Number of Participants with Fatal AEs assessed as related to study drug at Week 48
Measured: At Week 48
Number of Participants with Serious Adverse Events (SAEs) assessed as related to study drug at Week 48
Measured: 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
Measured: At Week 48
Minimum drug concentration (Cmin) of DTG
Measured: Up to Week 24
Cmin of RPV
Measured: Up to Week 24
Cmin of DTG at Week 4 Visit
Measured: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Cmin of RPV at Week 4 Visit
Measured: Pre-dose, 1, 2, 4, 5, 6, 10 and 24 hours (h) post-dose at Week 4
Concentration of HIV-1 RNA
Measured: 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)
Measured: 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)
Measured: Up to Week 48
Number of Participants with HIV-1 genotypes at Baseline, Week 24 and 48
Measured: Baseline (Day 1), Week 24 and 48
Number of Participants with Acceptability to JULUCA
Measured: At Week 4, 24 and 48
Number of Participants with Adherence to JULUCA
Measured: At Week 4, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start6 Jul 2023
- Primary completion1 Jun 2026 (estimated)
- Study completion3 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674656
- Sponsor's protocol ID
- 205868
- Other IDs
- 2022-000829-24
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05674656
- Acronym / sponsor ID
- 205868
- Conditions
- HIV Infections
- Keywords
- Dolutegravir, Rilpivirine, JULUCA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 3 May 2028 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dolutegravir(DTG)/Rilpivirine (RPV) | Experimental | Drug: Dolutegravir/Rilpivirine FDC |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir/Rilpivirine FDCAlso: JULUCADolutegravir/Rilpivirine will be administered. | Drug | Dolutegravir(DTG)/Rilpivirine (RPV) |
Primary outcome
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
19 secondary outcomes
Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL)
Time frame: At Week 24 and 48
Cluster of differentiation 4 (CD4+) Cell Count
Time frame: At Week 24 and 48
Percentage of CD4+ Cell Count
Time frame: At Week 24 and 48
Number of Participants with Adverse Events (AEs) at Week 48
Time frame: At Week 48
Number of Participants with Grade 3 or higher AEs at Week 48
Time frame: 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
Number of Participants with Fatal AEs assessed as related to study drug at Week 48
Time frame: 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
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
Minimum drug concentration (Cmin) of DTG
Time frame: Up to Week 24
Cmin of RPV
Time frame: 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
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
Concentration of HIV-1 RNA
Time frame: 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
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
Number of Participants with HIV-1 genotypes at Baseline, Week 24 and 48
Time frame: Baseline (Day 1), Week 24 and 48
Number of Participants with Acceptability to JULUCA
Time frame: At Week 4, 24 and 48
Number of Participants with Adherence to JULUCA
Time frame: At Week 4, 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. 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
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
ViiV Healthcare
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dolutegravir/Rilpivirine FDC in people with HIV Infections, run by ViiV Healthcare at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC0-24h) of DTG (time frame: Up to Week 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.