A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

NCT04012931 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1086062018-004301-32TMC278HTX2002
• Study Type: interventional
• Target: 26
• Locations: 6 countries
• Sites: 14

Brief 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.

Conditions

HIV

Outcome Measures

Primary Outcomes (4)

• 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)

  AUC(0-24h) was defined the area under the plasma concentration-time curve from time of administration up to 24 hours postdose of rilpivirine. As planned, data was not summarized for arms where number of participants analyzed was less than 3. Only individual participant data was available and reported in this outcome measure. Out of the 2 participants weighing \<20 kg who received rilpivirine 15 mg, 1 participant switched to rilpivirine 12.5 mg group after the first 4 weeks. This participant was counted in the \<20 kg rilpivirine 12.5 mg group for the pharmacokinetic assessments, hence the number of participants analyzed for this outcome measure in this arm are exceeding the participants that started this arm. As per protocol, the intensive PK samples were collected at anytime during Day 28 to Day 32 after first dose at the specified dose regimen.

  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)

  AUC(0-24h) was defined the area under the plasma concentration-time curve from time of administration up to 24 hours postdose of rilpivirine. As per protocol, the intensive PK samples were collected at anytime during Day 28 to Day 32 after first dose at the specified dose regimen.

  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)

  AUC(0-24h) was defined the area under the plasma concentration-time curve from time of administration up to 24 hours postdose of rilpivirine. As per protocol, the intensive PK samples were collected at anytime during Day 28 to Day 32 after first dose at the specified dose regimen.

  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)

  AUC(0-24h) was defined the area under the plasma concentration-time curve from time of administration up to 24 hours postdose of rilpivirine. As planned, data was not summarized for arms where number of participants analyzed was less than 3. Only individual participant data was available and reported in this outcome measure. As per protocol, the intensive PK samples were collected at anytime during Day 28 to Day 32 after first dose at the specified dose regimen.

  Predose up to 24 hour post-dose at anytime during Day 28 to Day 32 (Week 4)

Secondary Outcomes (14)

• Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 and >=50 Copies/mL Through Weeks 24 and 48

  From Day 1 up to Weeks 24 and 48

• Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <400 and >=400 Copies/mL Through Weeks 24 and 48

  From Day 1 up to Weeks 24 and 48

• Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count up to Week 24 and Week 48

  From baseline (Day 1) up to Weeks 24 and 48

• Predose Plasma Concentration (C[0h]) of Rilpivirine 12.5 mg (for <20 kg Group)

  Predose at anytime during Day 28 to Day 32 (Week 4)

• Predose Plasma Concentration (C[0h]) of Rilpivirine 15 mg (for <20 kg Group)

  Predose at anytime during Day 28 to Day 32 (Week 4)

Study Arms (1)

Rilpivirine (RPV) (25 mg or adjusted weight-based dose)

EXPERIMENTAL

Participants will receive rilpivirine (RPV 25 milligram \[mg\], adjusted weight-based dose) orally once daily in combination with an investigator selected background regimen (that is investigator-selected antiretrovirals \[ARVs\] such as nucleoside/nucleotide reverse transcriptase inhibitor \[N{t}RTIs\] and integrase inhibitors) for 48 weeks.

Drug: Rilpivirine; Drug: ARV Background Regimen

Interventions

Rilpivirine DRUG

Rilpivirine 25 mg tablets for the 25 mg daily dose, or tablets for or a weight-adjusted dose. Administered orally once daily.

Also known as: TMC278

Rilpivirine (RPV) (25 mg or adjusted weight-based dose)

ARV Background Regimen DRUG

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.

Rilpivirine (RPV) (25 mg or adjusted weight-based dose)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (14)

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, 00165, Italy

Location

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649 035, Portugal

Location

Uls Sao Joao - Hosp. Sao Joao

Porto, 4200 319, Portugal

Location

Josha Research

Bloemfontein, 9301, South Africa

Location

Family Clinical Research Unit FAM-CRU

Tygerberg, 7505, South Africa

Location

Hosp. Sant Joan de Deu

Esplugues de Llobregat, 08950, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

Research Institute for Health Sciences

Chiang Mai, 50200, Thailand

Location

Bamrasnaradura Infectious Disease Institute

Nonthaburi, 11000, Thailand

Location

Joint Clinical Research Centre

Kampala, 10005, Uganda

Location

MeSH Terms

Interventions

Rilpivirine

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Medical Head
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 9, 2019
• Study Start: July 18, 2019
• Primary Completion: February 17, 2023
• Study Completion: February 23, 2023
• Last Updated: February 4, 2025
• Results First Posted: May 2, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (3); ZA (2); UG (1); PT (2); ES (3); TH (3)