A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Parti… (NCT02494986) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies
Portugal, South Africa, Spain48 participantsStarted 2015-07-06
Plain-language summary
The purpose of this study is to provide continued access to rilpivirine (RPV) for participants 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.
Who can participate
Age range
0 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants (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)
* Participants must be human immunodeficiency virus type 1 (HIV-1) infected and must have previously been treated with rilpivirine (RPV) 25 mg qd (or weight-adjusted dose) in a clinical development pediatric study and completed the protocol-defined treatment period
* Participants 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 participant 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
* Participants must be able and willing to comply with the current protocol requirements
* Participants' general medical condition, in the opinion of the investigator, does not interfere with participation in this study
Exclusion Criteria:
* Participants using disallowed concomitant treatment
* Pregnant participants
* Female participants of childbearing potential and non-vasectomized heterosexually active male participants not willing to continue practicing birth control methods during the study and for greater than or equal to …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a roll-over study specifically for children and adolescents who were already in a rilpivirine pediatric trial, is my child eligible to continue in this study, or have they already missed the enrollment window since it's no longer actively recruiting?
2The study is closely tracking serious side effects like Grade 3 or 4 rash and other adverse events — based on what my child experienced in the earlier rilpivirine study, does their history put them at higher risk for any of these specific safety concerns?
3Since this is a Phase 2 study, what does that mean for how much we already know about rilpivirine's long-term safety in kids, and are there any gaps in the evidence my child's care team is still watching for?
4The trial is measuring pregnancies as a primary outcome — if my child is or could become pregnant, how would that affect their participation and their treatment plan?
5Given that this study is no longer enrolling new participants, what are the best alternative options for my child to continue accessing rilpivirine or a comparable HIV treatment if they can't join this roll-over study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with adverse events (AEs) related to rilpivirine (RPV)
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
2
Number of Participants with AEs Leading to Discontinuation
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
3
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
4
Number of Participants with Pregnancies
Timeframe: Up to 32 Days from the last dose of administered (Approximately 16 years)
5
Number or Participants with Grade 3/4 Rash Regardless of Causality
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)