A roll-over study with rilpivirine for human immunodeficiency virus type 1 (HIV-1) infected subjects who participated in rilpivirine pediatric studies

Phase 1

Conditions: HIV-1 Infection
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-002471-28-IT

Lead Sponsor: Janssen Sciences Ireland Unlimited Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 100

Inclusion Criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study.
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).
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.
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.
4. Subjects must be able and willing to comply with the current protocol requirements.
5. Subjects’ general medical condition, in the opinion of the investigator, does not interfere with participation in this study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 11
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any potential subject who meets any of the following criteria will be excluded from participating in the study.
1. Subjects using disallowed concomitant treatment.
2. Pregnant subjects.
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 (or after last intake of RPV). Effective birth control methods are:
a. male condom* in combination with diaphragm or cervical cap**;
b. intrauterine device or hormonal contraceptive in combination with a barrier contraceptive (ie, male or female condom*, diaphragm, or cervical cap**);
c. practice sexual abstinence, or have no heterosexual interaction, or have a vasectomized
partner (vasectomy should have been performed >1 month prior to withdrawal of these other effective birth control methods).
* A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
** A cervical cap has been shown to be less effective in parous women. Therefore, this barrier method is preferably not used in parous women in this trial.
Note: Spermicides should not be used as this can potentially increase the rate of HIV-1 transmission.20
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.
NOTE: Investigators should ensure that all study enrollment criteria have been met at the Roll-over Visit.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to provide continued access to RPV for subjects who were treated with RPV in a clinical development pediatric study with rilpivirine and who, at the time of roll-over, experience and are expected to continue experiencing clinical benefit from RPV treatment;Secondary Objective: The major secondary objective is to evaluate the long-term safety and tolerability of RPV in combination with a background regimen containing other ARVs. Another secondary objective is to evaluate available efficacy data, including HIV-1 resistance data in case of virologic failure.;Primary end point(s): No primary endpoint is defined for this study;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The proportion of subjects experiencing adverse events (AEs) considered to be at least possibly related to RPV, AEs leading to discontinuation, serious AEs (SAEs), pregnancies, and grade 3/4 rash regardless of causality throughout the study. Results of routine safety laboratory tests will only be collected if related to these types of AEs.; The proportion of subjects maintaining viral suppression (ie, <50 HIV-1 RNA copies/mL) based on available viral load data throughout the study. In case of virologic failure, emergence of resistance will also be evaluated based on available genotype/phenotype data.;Timepoint(s) of evaluation of this end point: Throughout the study; Throughout the study

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