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Clinical trial

A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

ID
Name
CR108606
Description
The purpose of this study is to evaluate the steady state pharmacokinetics (PK) of rilpivirine (RPV) and determine the appropriate dose of RPV in combination with other antiretrovirals (ARVs) in participants aged greater than or equal to 2 to less than 12 years and to evaluate the safety and tolerability of RPV in combination with other ARVs in participants of same age group over a 48-week treatment period with primary endpoint at Week 24.
Trial arms
Trial start
2019-07-18
Estimated PCD
2023-02-17
Trial end
2023-02-23
Status
Completed
Phase
Early phase I
Treatment
Rilpivirine
Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.
Arms:
Rilpivirine (RPV) (25 mg or adjusted weight-based dose)
Other names:
TMC278
ARV Background Regimen
The investigator-selected ARVs, including but not limited to N(t)RTIs (example, azidothymidine \[AZT\], abacavir \[ABC\], tenofovir alafenamide \[TAF\], or tenofovir disoproxil fumarate \[TDF\] in combination with emtricitabine \[FTC\] or lamivudine \[3TC\]), whichever are approved and marketed or considered local standard of care for children aged between 2 and \< 12 years in a particular country are to be administered. Integrase inhibitors (for example, dolutegravir \[DTG\] or raltegravir) can also be administered in combination with RPV, as appropriate.
Arms:
Rilpivirine (RPV) (25 mg or adjusted weight-based dose)
Size
26
Primary endpoint
Area Under the Plasma Concentration-time Curve From Time of Administration up to 24 Hours Postdose (AUC[0-24h]) of Rilpivirine 12.5 mg (for <20 kg Group)
Predose up to 24 hour post-dose at anytime during Day 28 to Day 32 (Week 4)
Area Under the Plasma Concentration-time Curve From Time of Administration up to 24 Hours Postdose (AUC[0-24h]) of Rilpivirine 15 mg (for <20 kg Group)
Predose up to 24 hour post-dose at anytime during Day 28 to Day 32 (Week 4)
Area Under the Plasma Concentration-time Curve From Time of Administration up to 24 Hours Postdose (AUC[0-24h]) of Rilpivirine 15 mg (for 20 to <25 mg Group)
Predose up to 24 hour post-dose at anytime during Day 28 to Day 32 (Week 4)
Area Under the Plasma Concentration-time Curve From Time of Administration up to 24 Hours Postdose (AUC[0-24h]) of Rilpivirine 25 mg (for >=25 kg Group)
Predose up to 24 hour post-dose at anytime during Day 28 to Day 32 (Week 4)
Eligibility criteria
Inclusion Criteria: * Weighing at least 10 kilogram (kg) at screening * Have documented chronic Human Immunodeficiency Virus (HIV-1) infection * On a stable antiretroviral (ARV) regimen for at least 6 months prior to screening and virologically suppressed with documented evidence of at least 2 plasma viral loads less than (\<) 50 HIV-1 ribonucleic acid (RNA) copies/milliliter (mL): one within 2-12 months prior to screening and one at screening * Can switch from any ARV class * Never been treated with a therapeutic HIV vaccine * Historical HIV-1 genotyping result at screening for children aged \>=2 to \<6 years (and for children aged \>=6 to \<12 years if a historical HIV-1 genotyping result is available at screening) must demonstrate sensitivity to RPV and to the selected background ARVs Exclusion Criteria: * Have previously documented HIV-2 infection * Have known or suspected acute (primary) HIV-1 infection * Taken any disallowed concomitant therapies within 4 weeks before the planned first dose of study intervention * Any current or history of adrenal disorder * A history of virologic failure to ARVs with or without availability of an HIV-1 genotype result at the time of failure
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2024-05-02

1 organization

2 products

1 indication

Organization
Janssen Research & Development
Product
Rilpivirine
Indication
HIV
Product
ARV Background Regimen