HIV drug rilpivirine keeps helping kids in Long-Term study
NCT ID NCT02494986
First seen Jun 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This study gives children with HIV-1 who previously benefited from rilpivirine continued access to the drug along with other antiretrovirals. About 48 kids are taking part to monitor long-term safety and side effects. The goal is to keep their virus under control while checking for any problems over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rilpivirine (an antiretroviral drug)
- What this could lead to
- If successful, this study could confirm that rilpivirine is safe and effective for long-term use in children with HIV, helping them manage the virus.
- What could go wrong
- This is a small, open-label roll-over study (Phase 2) with no comparison group, so results may not apply broadly. Side effects like rash or serious adverse events are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
48 people
The number who actually took part.
- Started
-
Jul 2015
- Expected to finish
-
Aug 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
0 days and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (≥)1 month after the end of the study (or after last intake of RPV) * Participants 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Study site
Porto, Portugal
-
Study site
Bloemfontein, South Africa
-
Study site
Dundee, South Africa
-
Study site
Esplugues de Llobregat, Spain
-
Study site
Bangkok, Thailand
-
Study site
Nonthaburi, Thailand
-
Study site
Entebbe, Uganda
-
Study site
Kampala, Uganda
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