CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 149 enrolled
Drug / intervention
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01209325
NCT01209325Phase 2Completed
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AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

AIDS Malignancy Consortium·interventional·Posted Sep 27, 2010·Updated Aug 11, 2020

In Brief

A Phase 2 clinical trial evaluating quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine and laboratory biomarker analysis for Anal Cancer and 3 related conditions. Completed, enrolled 149 participants across 19 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Cancer, Nonneoplastic Condition, Penile Cancer, Precancerous Condition
CountriesPuerto Rico, United States
CollaboratorsNational Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, Merck Sharp & Dohme LLC, AIDS and Cancer Specimen Resource

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 27, 2010
Enrollment StartJun 28, 2011
Primary CompletionDec 12, 2017
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 15.8 years ago

Interventions

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccinebiological

laboratory biomarker analysisother