NCT05674656 Pharmacokinetics, Safety, Tolerability of Dolutegravir/Rilpivirine in Pediatrics
| NCT ID | NCT05674656 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ViiV Healthcare |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-07-06 |
| Primary Completion | 2026-06-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * 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 th
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