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Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-12
SponsorViiV Healthcare

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dolutegravir/Rilpivirine FDC

    Drug

    Dolutegravir/Rilpivirine will be administered.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Dolutegravir(DTG)/Rilpivirine (RPV)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under the curve (AUC0-24h) of DTG

Time frame
Up to Week 24
2

Area under the curve (AUC0-24h) of RPV

Time frame
Up to Week 24
3

Number of Participants with Adverse Events (AEs) at Week 24

Time frame
At Week 24
4

Number of Participants with Grade 3 or higher AEs at Week 24

Time frame
At Week 24

Secondary outcomes

1

Proportion of Participants with HIV-1 RNA less than 50 copies per milliliter (c/mL)

Time frame
At Week 24 and 48
2

Cluster of differentiation 4 (CD4+) Cell Count

Time frame
At Week 24 and 48
3

Percentage of CD4+ Cell Count

Time frame
At Week 24 and 48
4

Number of Participants with Adverse Events (AEs) at Week 48

Time frame
At Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ViiV Healthcare

Lead sponsor

Janssen Research & Development, LLC

Collaborator

Source ClinicalTrials.gov
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