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NCT02494986

A Roll-over Study With Rilpivirine for Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Who Participated in Rilpivirine Pediatric Studies

StatusCompleted
PhasePhase 2
Primary completion
Track this trial

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Record History

The 50 most recent of 88 versions: 21 with changes below, 29 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 5 entries
    • Trial completed
    • Eligibility criteria expanded, about 9 words
    • Study description revised
  2. Study completion moved earlier from Jun 30, 2027 to Aug 18, 2026v86
  3. Primary completion date: Jun 30, 2027 to Aug 18, 2026v82
  4. Study completion date: Dec 31, 2031 to Jun 30, 2027v74
  5. Primary completion date: Jun 2027 to Jun 30, 2027
    • Study completion date: Dec 2031 to Dec 31, 2031
    • Start date: Jul 2015 to Jul 6, 2015
    v68
Show 16 earlier versionsHide 16 earlier versions
  1. Primary completion date: Dec 2030 to Jun 2027v67
  2. Primary completion date: Dec 31, 2030 to Dec 2030
    • Study completion date: Dec 31, 2031 to Dec 2031
    • Start date: Jul 6, 2015 to Jul 2015
    v62
  3. Primary completion date: Dec 2030 to Dec 31, 2030
    • Study completion date: Dec 2031 to Dec 31, 2031
    • Start date: Jul 2015 to Jul 6, 2015
    v60
  4. Primary completion date: Dec 31, 2030 to Dec 2030
    • Study completion date: Dec 31, 2031 to Dec 2031
    • Start date: Jul 6, 2015 to Jul 2015
    v54
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 50 to confirmed 48
    • Study sites: 14 to 8
    v51
  6. Site details revised at 1 of 14 sitesv50
  7. Site details revised at 1 of 14 sitesv49
  8. Study sites revised (14)v47
  9. Site details revised at 1 of 14 sitesv46
  10. Site details revised at 1 of 14 sitesv45
  11. Site details revised at 1 of 14 sitesv44
  12. Site details revised at 1 of 14 sitesv43
  13. Study sites: 13 to 14v42
  14. Primary completion date: Dec 2030 to Dec 31, 2030
    • Study completion date: Dec 2031 to Dec 31, 2031
    • Start date: Jul 2015 to Jul 6, 2015
    • Site details revised at 5 of 13 sites
    v41
  15. Primary completion date: Dec 31, 2030 to Dec 2030
    • Study completion date: Dec 31, 2031 to Dec 2031
    • Start date: Jul 6, 2015 to Jul 2015
    • Site details revised at 1 of 13 sites
    v40
  16. Site details revised at 1 of 13 sitesv39
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of participants with adverse events (AEs) related to rilpivirine (RPV)
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
Number of Participants with AEs Leading to Discontinuation
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)
Number of Participants with Pregnancies
Timeframe: Up to 32 Days from the last dose of administered (Approximately 16 years)
Number or Participants with Grade 3/4 Rash Regardless of Causality
Timeframe: Up to 32 Days from the last dose administered (Approximately 16 years)

Arms and interventions

RilpivirineExperimental

Participants will continue to receive oral tablets of rilpivirine (RPV) 25 milligram once daily (mg qd) or a weight-adjusted dose, in combination with an investigator selected background regimen consisting of other antiretrovirals (ARVs).

Drugs: Rilpivirine

Sites

8 sites in 5 countries

South Africa 2, Thailand 2, Uganda 2, Portugal 1, Spain 1