Phase 2
Completed N=26
A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed
Source: ClinicalTrials.gov NCT04012931 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: 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) — 4116; 4646 nanograms*hour/milliliter (ng*h/mL)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
4116; 4646 | — |
| PRIMARY 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) |
3494 | — |
| PRIMARY 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) |
3506 | — |
| PRIMARY 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) |
4514; 5644 | — |
| SECONDARY Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 and >=50 Copies/mL Through Weeks 24 and 48 |
100.0; 100.0; 0.0; 0.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <400 and >=400 Copies/mL Through Weeks 24 and 48 |
100.0; 100.0; 0.0; 0.0; 100.0; 100.0 | — |
| SECONDARY Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count up to Week 24 and Week 48 |
313.0; 26.3; 279.0; -19.9 | — |
| SECONDARY Predose Plasma Concentration (C[0h]) of Rilpivirine 12.5 mg (for <20 kg Group) |
116; 161 | — |
| SECONDARY Predose Plasma Concentration (C[0h]) of Rilpivirine 15 mg (for <20 kg Group) |
79.3 | — |
| SECONDARY Predose Plasma Concentration (C[0h]) of Rilpivirine 15 mg (for 20 to <25 kg Group) |
138 | — |
| SECONDARY Predose Plasma Concentration (C[0h]) of Rilpivirine 25 mg (for >=25 kg Group) |
146; 342 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Rilpivirine 12.5 mg (for <20 kg Group) |
273; 318 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Rilpivirine 15 mg (for <20 kg Group) |
214 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Rilpivirine 15 mg (for 20 to <25 mg Group) |
217 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Rilpivirine 25 mg (for >=25 kg Group) |
309; 418 | — |
| SECONDARY Percentage of Participants With Viral Genotype at the Time of Virologic Failure at Weeks 24 and 48 |
— | — |
| SECONDARY Percentage of Participants With Treatment Adherence >95% Based on Tablet Count up to Weeks 24 and 48 |
100.0; 86.4; 100.0; 90.9 | — |
| SECONDARY Change From Baseline in Percentage of Cluster of Differentiation 4 (CD4+) Cell Count up to Week 24 and Week 48 |
5.3; 1.2; 6.4; 0.7 | — |
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 ( =2 to =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
Data sourced from ClinicalTrials.gov (NCT04012931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.