Who is sponsoring NCT01209325?

NCT01209325 is sponsored by AIDS Malignancy Consortium.

What condition does NCT01209325 study?

NCT01209325 studies Anal Cancer, Nonneoplastic Condition, Penile Cancer, Precancerous Condition.

Is NCT01209325 still recruiting?

NCT01209325 is currently completed. Last updated 11 August 2020.

Are results published for NCT01209325?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-11 · How we verify

NCT01209325

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 11 August 2020

What this trial tests

Phase 2 trial testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in Anal Cancer in 149 participants. Completed in 12 December 2017.

Timeline

28 June 2011

Primary endpoint
12 December 2017

12 December 2017

Quick facts

Lead sponsor	AIDS Malignancy Consortium
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	149
Start date	28 June 2011
Primary completion	12 December 2017
Estimated completion	12 December 2017
Sites	19 locations across Puerto Rico, United States

Drugs / interventions tested

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
laboratory biomarker analysis — full drug profile →

Conditions studied

Anal Cancer — all drugs for Anal Cancer →
Nonneoplastic Condition — all drugs for Nonneoplastic Condition →
Penile Cancer — all drugs for Penile Cancer →
Precancerous Condition — all drugs for Precancerous Condition →

Sponsor

AIDS Malignancy Consortium

Who can join

Adults 13 to 26, male only, with Anal Cancer or Nonneoplastic Condition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 6	0.0
Prior Exposure to HPV 6	11.1

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 11	0.0
Prior Exposure to HPV 11	2.2

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 16	0.0
Prior Exposure to HPV 16	4.5

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 18	0.0
Prior Exposure to HPV 18	2.8

Incidence of Persistent Anogenital Infection With HPV 6 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 6	1.8
Prior Exposure HPV 6	0.0

Incidence of Persistent Anogenital Infection With HPV 11 DNA Primary · Post Month 7 through Month 24

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.

Group	Value	95% CI
Naive to HPV 11	0.0
Prior Exposure to HPV 11	0.0

Incidence of Persistent Anogenital Infection With HPV 16 DNA Primary · Post Month 7 through Month 24

Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.

Group	Value	95% CI
Naive to HPV 16	2.9
Prior Exposure to HPV 16	0.0

Incidence of Persistent Anogenital Infection With HPV 18 DNA Primary · Post Month 7 through Month 24

Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site.

Group	Value	95% CI
Naive to HPV 18	0.7
Prior Exposure to HPV 18	0.0

Incidence of HGAIN Associated With HPV 6 Primary · Post month 7 through month 24

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.

Group	Value	95% CI
Naive to HPV 6	0.0
Prior Exposure to HPV 6	10.4

Incidence of HGAIN Associated With HPV 11 Primary · Post month 7 through month 24

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline.

Group	Value	95% CI
Naive to HPV 11	0.0
Prior Exposure to HPV 11	1.7

Incidence of HGAIN Associated With HPV 16 Primary · Post month 7 through month 24

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline.

Group	Value	95% CI
Naive to HPV 16	0.0
Prior Exposure to HPV 16	8.4

Incidence of HGAIN Associated With HPV 18 Primary · Post month 7 through month 24

Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline.

Group	Value	95% CI
Naive to HPV 18	0.0
Prior Exposure to HPV 18	2.7

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment through 2 years after the first injection of Gardasil.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Vaccination

Serious: 5/144 (3%)

Deaths: 0/144

Serious adverse events (7 terms)

Reaction	System	Vaccination
Skin infection	Infections and infestations	—
Gum infection	Infections and infestations	—
Vomiting	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Psychiatric disorders - other, specify	Psychiatric disorders	—
Suicidal ideation	Psychiatric disorders	—
Suicide attempt	Psychiatric disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Vaccination
Injection site reaction	General disorders	—
Skin and subcutaneous tissue disorder - other, specify	Skin and subcutaneous tissue disorders	—
Neutrophil count decreased	Investigations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Diarrhea	Gastrointestinal disorders	—

Most-reported serious reactions: Skin infection, Gum infection, Vomiting, Nausea, Psychiatric disorders - other, specify, Suicidal ideation, Suicide attempt.

Data from ClinicalTrials.gov NCT01209325 adverse events section.

Sponsor's own description

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection. PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Projected Cancer Incidence Rates and Burden of Incident Cancer Cases in HIV-Infected Adults in the United States Through 2030.
Shiels MS, Islam JY, Rosenberg PS, Hall HI, et al · · 2018 · cited 145× · PMID 29801099 · DOI 10.7326/m17-2499
Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men.
Kahn JA, Belzer M, Chi X, Lee J, et al · · 2019 · cited 24× · PMID 30658128 · DOI 10.1016/j.pvr.2019.01.002
Post-Immune Antibodies in HIV-1 Infection in the Context of Vaccine Development: A Variety of Biological Functions and Catalytic Activities.
Timofeeva A, Sedykh S, Nevinsky G. · · 2022 · cited 12× · PMID 35335016 · DOI 10.3390/vaccines10030384
The role of Human Papilloma Virus (HPV) vaccination in the prevention of anal cancer in individuals with Human Immunodeficiency Virus-1 (HIV-1) infection.
Barroso LF. · · 2013 · cited 9× · PMID 24757517 · DOI 10.1177/2051013613496946

Verify or expand the search:

Other recruiting trials for Anal Cancer

Currently open trials in the same condition.

NCT07192055 — Self-sampling to Optimize Anal Lesion Outcomes · NA · recruiting
NCT07296237 — Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer · recruiting
NCT07124000 — DESTINY-PANTUMOUR04 · recruiting
NCT05639972 — E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers · Phase 1, PHASE2 · recruiting
NCT06670495 — HPV Genotype Attribution and Disease Burden of Anal Cancer in China · recruiting

Other AIDS Malignancy Consortium trials

Trials by the same sponsor.

NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men · withdrawn
NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men · withdrawn
NCT05077527 — Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma · Phase 1 · recruiting
NCT04305691 — Trial of Ixazomib for Kaposi Sarcoma · Phase 2 · recruiting
NCT05510908 — Use of a Screening Tool to Describe HIV-Related Cancer Burden and Patient Characteristics in the AMC · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01209325 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AIDS Malignancy Consortium
Last refreshed: 11 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01209325.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing