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NCT01209325 · OUTCOME

Incidence of Persistent Anogenital Infection With HPV 6 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 HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.

Analysis population: All eligible participants who were HPV 6 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

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 HPV 6

HPV 6 positive based on serum at visit 0 from any anatomical site.

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 629
Prior Exposure HPV 615

Reported measurements

Source class 1
Values in events per 100 person years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Naive to HPV 61.8Not reportedNot reportedNot reportedNot reported
Prior Exposure HPV 60.0Not 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
    0.671
    p Value Comment
    Two-sided p-value is comparing naive and prior exposure groups for HPV 6.
    statistical Method
    Exact Poisson calculation
  2. group Description
    This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.312
    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
    0.671
    p Value Comment
    Two-sided p-value is comparing naive and prior exposure groups for HPV 6.
    statistical Method
    Exact Poisson calculation
  2. group Description
    This study's Naive to HPV 6 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 6 (NCT00090285), 1.8 events per 100 person years (PY) versus 4.5 events per 100 PY, respectively.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.312
    p Value Comment
    One-sided p-value.
    statistical Method
    Exact Poisson calculation
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.8
      2. group Id
        OG001
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.
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 from any anatomical site.
    id
    OG001
    title
    Prior Exposure HPV 6
param Type
NUMBER
population Description
All eligible participants who were HPV 6 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
reporting Status
POSTED
time Frame
Post Month 7 through Month 24
title
Incidence of Persistent Anogenital Infection With HPV 6 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