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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Drug: ARV Background Regimen; Drug: Rilpivirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04012931

TMC278HTX2002 (Other Identifier)

2018-004301-32 (EudraCT Number)

CR108606

Details and patient eligibility

About

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.

Full description

Participants infected with human immunodeficiency virus type 1 (HIV-1) are routinely treated with combinations of multiple drugs which reduces HIV-1 ribonucleic acid (RNA) to undetectable levels in a substantial proportion of participants and counteracts the risk of viral resistance development. RPV is a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type (WT) HIV-1 and against NNRTI-resistant HIV-1 mutants. A medical need still exists for the development of age/weight appropriate formulations in children less than (<) 12 years of age. In this study, participants will switch to RPV plus other ARVs. The primary analysis will be performed at Week 24. A participant will be considered to have completed the study if he or she has completed assessments at Week 48 of the study intervention phase. The total study duration for each participant, including screening and study intervention phases, will be approximately 54 weeks. Key efficacy assessments include determination of plasma HIV-1 RNA viral load and measurement of CD4+ cell count. Key safety assessments will include the monitoring of (serious) adverse events ([S]AEs) and HIV-related events, clinical laboratory tests, cardiovascular safety monitoring (vital signs and 12 lead electrocardiogram [ECGs]), and physical examination (including growth).

Enrollment: 26 patients

Sex: All

Ages: 2 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Drug: Rilpivirine

Drug: ARV Background Regimen