NCT01209325 · OUTCOME

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 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 16 positive DNA in participants without HPV-16 related AIN at baseline.

Analysis population: Eligible participants without prevalent HPV 16 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 16

HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.

Prior Exposure to HPV 16

HPV 16 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

Group	Source count
Naive to HPV 16	39
Prior Exposure to HPV 16	29

Reported measurements

Source class 1

Values in Events per 100 person years · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Naive to HPV 16	0.0	Not reported	Not reported	Not reported	Not reported
Prior Exposure to HPV 16	4.5	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.079
p Value Comment
Two-sided p-value.
statistical Method
Exact poisson test
group Description
This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.350
p Value Comment
One-sided p-value.
statistical Method
Exact Poisson calculation

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.079
p Value Comment
Two-sided p-value.
statistical Method
Exact poisson test
group Description
This study's Naive to HPV 16 group was compared to the per-protocol Merck 020 historical placebo group naive to HPV 16 (NCT00090285), 0.0 events per 100 person years (PY) versus 1.8 events per 100 PY, respectively.
group Ids
OG000
non Inferiority Type
SUPERIORITY
p Value
0.350
p Value Comment
One-sided p-value.
statistical Method
Exact Poisson calculation

classes

categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
4.5

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
29
units
Participants

description

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.

groups

description
HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
id
OG000
title
Naive to HPV 16
description
HPV 16 positive based on serum at visit 0.
id
OG001
title
Prior Exposure to HPV 16

param Type

NUMBER

population Description

Eligible participants without prevalent HPV 16 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 16 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