Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics

Part of paid clinical trials in Long Beach, California.

Sponsor
ViiV Healthcare
Study ID
NCT05674656
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Dolutegravir/Rilpivirine FDC — DRUG
    Dolutegravir/Rilpivirine will be administered.

Study Details

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).

Key Dates

Start date
Jul 6, 2023
Status verified
Sep 2024
Primary completion
Jun 1, 2026
Completion
May 3, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dolutegravir(DTG)/Rilpivirine (RPV)

Primary Outcome Measure

Area under the curve (AUC0-24h) of DTG [ Time Frame: Up to Week 24 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLong BeachCalifornia90806
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Jagmohan Batra (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWashington D.C.District of Columbia20010
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Natella Rakhmanina (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteFort LauderdaleFlorida33316-
GSK Investigational SiteMiamiFlorida33136
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Charles Mitchell (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteTampaFlorida33606
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Carina Rodriguez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAtlantaGeorgia30322
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Andres Camacho-Gonzalez (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77030
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Gloria Heresi (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77030
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Susan Gillespie (PRINCIPAL_INVESTIGATOR)

Find similar trials in Long Beach, CA

By condition
HIV
By specialty
Infectious disease
By research site
GSK Investigational Site· Long Beach, CAGSK Investigational Site· Washington D.C., DCGSK Investigational Site· Fort Lauderdale, FLGSK Investigational Site· Miami, FLGSK Investigational Site· Tampa, FLGSK Investigational Site· Atlanta, GA

Related Studies