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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 age, weighing at least 25 kilogram (kg).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
GSK Investigational Site
RECRUITING
Long Beach
Washington, D.c.
GSK Investigational Site
RECRUITING
Washington D.c.
Florida
GSK Investigational Site
COMPLETED
Fort Lauderdale
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Tampa
Georgia
GSK Investigational Site
RECRUITING
Atlanta
Texas
GSK Investigational Site
RECRUITING
Houston
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2023-07-06
Estimated Completion Date: 2028-05-03
Participants
Target number of participants: 20
Treatments
Experimental: Dolutegravir(DTG)/Rilpivirine (RPV)
Related Therapeutic Areas
Sponsors
Leads: ViiV Healthcare
Collaborators: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov