Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01209325 · OUTCOME

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA

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
Events 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 AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.

Analysis population: Eligible participants without prevalent HPV 18 related AIN 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 18

HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Prior Exposure to HPV 18

HPV 18 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 1847
Prior Exposure to HPV 1823

Reported measurements

Source class 1
Values in Events per 100 person years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Naive to HPV 180.0Not reportedNot reportedNot reportedNot reported
Prior Exposure to HPV 182.8Not 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
    0.162
    statistical Method
    Exact poisson test
  2. group Description
    This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.490
    p Value Comment
    One-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
    0.162
    statistical Method
    Exact poisson test
  2. group Description
    This study's Naive to HPV 18 group was compared to the Merck 020 per-protocol historical placebo group naive to HPV 18 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.0 events per 100 PY, respectively.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.490
    p Value Comment
    One-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
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.
groups
  1. description
    HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
    id
    OG000
    title
    Naive to HPV 18
  2. description
    HPV 18 positive based on serum at visit 0.
    id
    OG001
    title
    Prior Exposure to HPV 18
param Type
NUMBER
population Description
Eligible participants without prevalent HPV 18 related AIN 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 AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
type
PRIMARY
unit Of Measure
Events per 100 person years

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

Preserved source evidence · Not medical advice