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NCT01209325 · OUTCOME

Incidence of HGAIN Associated With HPV 6

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
per 100 person years
Interval / dispersion
Not reported
Time frame
Post month 7 through month 24

What was measured

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.

Analysis population: Eligible participants without prevalent HPV 6 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Groups in this outcome

Naive to HPV 6

HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Prior Exposure to HPV 6

HPV 6 positive based on serum at visit 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Naive to HPV 615
Prior Exposure to HPV 656

Reported measurements

Source class 1
Values in per 100 person years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Naive to HPV 60.0Not reportedNot reportedNot reportedNot reported
Prior Exposure to HPV 610.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.064
    p Value Comment
    Two-sided p-value.
    statistical Method
    Exact Poisson calculation
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.064
    p Value Comment
    Two-sided p-value.
    statistical Method
    Exact Poisson calculation
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        10.4
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      56
    units
    Participants
description
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.
groups
  1. description
    HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
    id
    OG000
    title
    Naive to HPV 6
  2. description
    HPV 6 positive based on serum at visit 0.
    id
    OG001
    title
    Prior Exposure to HPV 6
param Type
NUMBER
population Description
Eligible participants without prevalent HPV 6 related HGAIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
reporting Status
POSTED
time Frame
Post month 7 through month 24
title
Incidence of HGAIN Associated With HPV 6
type
PRIMARY
unit Of Measure
per 100 person years

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice