NCT01209325 · STUDY IN CONTEXT

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.

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

→

primary · POSTED

Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.

Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

→

primary · POSTED

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.

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.

→

primary · POSTED

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.

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.

→

primary · POSTED

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.

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.

→

primary · POSTED

Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.

All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-penile-cancer
nct id: NCT01209325
trial label: Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0000
source section id
NCT01209325-om-0000
source outcome index
0
endpoint
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
endpoint definition
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants without prevalent HPV 6 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0001
source section id
NCT01209325-om-0001
source outcome index
1
endpoint
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
endpoint definition
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0002
source section id
NCT01209325-om-0002
source outcome index
2
endpoint
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA
endpoint definition
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.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0003
source section id
NCT01209325-om-0003
source outcome index
3
endpoint
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
endpoint definition
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.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0004
source section id
NCT01209325-om-0004
source outcome index
4
endpoint
Incidence of Persistent Anogenital Infection With HPV 6 DNA
endpoint definition
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.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0005
source section id
NCT01209325-om-0005
source outcome index
5
endpoint
Incidence of Persistent Anogenital Infection With HPV 11 DNA
endpoint definition
Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.
time origin
Post Month 7 through Month 24
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All eligible participants who were HPV 11 DNA negative at baseline and received at least one vaccination and returned after month 7 with evaluable PCR tests at two consecutive visits.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0000
arm key
OG000
arm label
Naive to HPV 6
regimen
HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0000
arm key
OG001
arm label
Prior Exposure to HPV 6
regimen
HPV 6 positive based on serum at visit 0.
analyzed count
34
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0001
arm key
OG000
arm label
Naive to HPV 11
regimen
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
35
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0001
arm key
OG001
arm label
Prior Exposure to HPV 11
regimen
HPV 11 positive based on serum at visit 0.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0002
arm key
OG000
arm label
Naive to HPV 16
regimen
HPV 16 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0002
arm key
OG001
arm label
Prior Exposure to HPV 16
regimen
HPV 16 positive based on serum at visit 0.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0003
arm key
OG000
arm label
Naive to HPV 18
regimen
HPV 18 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
47
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0003
arm key
OG001
arm label
Prior Exposure to HPV 18
regimen
HPV 18 positive based on serum at visit 0.
analyzed count
23
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0004
arm key
OG000
arm label
Naive to HPV 6
regimen
HPV 6 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0004
arm key
OG001
arm label
Prior Exposure HPV 6
regimen
HPV 6 positive based on serum at visit 0 from any anatomical site.
analyzed count
15
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0005
arm key
OG000
arm label
Naive to HPV 11
regimen
HPV 11 negative based on serum at visit 0 and DNA from visit 0 and 3 from any anatomical site.
analyzed count
55
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
outcome key
om-0005
arm key
OG001
arm label
Prior Exposure to HPV 11
regimen
HPV 11 positive based on serum at visit 0 from any anatomical site.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01209325-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT01209325
harm key
EG000
source section id
NCT01209325-ae
event group key
EG000
event group label
Vaccination
serious affected
5
serious at risk
144
other affected
59
other at risk
144
frequency threshold
5
collection period
From enrollment through 2 years after the first injection of Gardasil.
event definition
All adverse events (AEs), regardless of severity, and whether or not ascribed to the study vaccine administration, were recorded. All Grade ≥ 2 laboratory values (except for CD4 cell counts) were recorded as AEs. After Week 32, only SAEs and AEs or symptoms \> grade 3 or symptoms that were possibly, probably, or definitely related to the study vaccine were recorded. Subjects who were withdrawn from the study due to AEs were to be followed by the Investigator until the outcome was determined.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice