Clinical trial • Phase IV • Infectious Disease

Rilpivirine for HIV-1 infection

Phase IV trial of Rilpivirine for HIV-1 infection. open-label. 40 participants.

Overview

open-label Phase IV trial across 2 sites in Italy.

Recruits 40 paediatric patients.

Pregnancy Exclusion: 2. Pregnant subjects.
Vulnerable Population: Vulnerable population selected. Consent must be provided by the subject or their legally acceptable representative. Assent is required of children capable of understanding the nature of the study (typically 7 years of age and older). Subject information and ICF/assent documents exist for parent/guardian and for child/adolescent (titles indicate Italian and English versions are available).

{"criterion_text":"- 1. Subjects (or their legally acceptable representative) must sign an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older)."}
{"criterion_text":"- 2. Subjects must be HIV-1 infected and must have previously been treated with RPV 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period."}
{"criterion_text":"- 3. Subjects must benefit from treatment with RPV, according to the efficacy and safety criteria as set out in the protocol of the pediatric study with RPV the subject was participating in prior to this rollover study, and must be expected to continue to benefit from this treatment in the opinion of the investigator."}
{"criterion_text":"- 4. Subjects must be able and willing to comply with the current protocol requirements."}
{"criterion_text":"- 5. Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study."}

{"criterion_text":"- 1. Subjects using disallowed concomitant treatment."}
{"criterion_text":"- 2. Pregnant subjects."}
{"criterion_text":"- 3. Female subjects of childbearing potential and non-vasectomized heterosexually active male subjects not willing to continue practicing birth control methods during the study and for ≥1 month after the end of the study."}
{"criterion_text":"- 4. Subjects who were withdrawn from a pediatric study with RPV that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria."}

{"endpoint_text":"- No primary endpoint is defined for this study.","definition_or_measurement_approach":""}

Planned Sample Size: 40
Recruitment Window Months: 63
Consent Approach: Informed Consent must be signed by the subject or their legally acceptable representative. Assent is required for children capable of understanding the study (typically 7 years and older). Subject information and ICF/assent documents are provided (documents in the dossier include Parent/Guardian ICFs and Assent forms for Child and Adolescent; document titles indicate Italian (IT_ITA) and English (IT_ENG) versions are available).

Site Name: Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name: Dipartimento di Scienze Mediche Traslazionali Malattie Infettive Pediatriche
Contact Person Name: Alfredo Guarino
Contact Person Email: alfguari@unina.it

Name: IQVIA RDS (India) Private Limited
Responsibilities: sponsorDuties code: 6; contact email: harshada.harishchandrahate@iqvia.com; phone: 918071317777

{"country":"India","full_name":"IQVIA RDS (India) Private Limited","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}

Other published trials that may interest you.