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

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.

Timeline

Start

2011-06-28

Primary completion

2017-12-12

Completion

2017-12-12

Outcome

Mixed primary results

registry NUMBER Naive to HPV 16: 0.0 per 100 person years NCT01209325 ↗

registry NUMBER Prior Exposure to HPV 16: 8.4 per 100 person years NCT01209325 ↗

registry analysis (superiority test); Naive to HPV 16 vs Prior Exposure to HPV 16; p = 0.014; Exact Poisson calculation NCT01209325 ↗

registry NUMBER Naive to HPV 6: 0.0 Events per 100 person years NCT01209325 ↗

registry NUMBER Prior Exposure to HPV 6: 11.1 Events per 100 person years NCT01209325 ↗

registry analysis (superiority test); Naive to HPV 6 vs Prior Exposure to HPV 6; p = 0.112; Exact poisson test; note: Two-sided p-value NCT01209325 ↗

Publications

• Kahn JA, Belzer M, Chi X, Lee J, Gaur AH, Mayer K, Martinez J, Futterman DC, Stier EA, Paul ME, Chiao EY, Reirden D, Goldstone SE, Ortiz Martinez AP, Cachay ER, Barroso LF, Da Costa M, Wilson CM, Palefsky JM; AIDS Malignancy Consortium and Adolescent Medicine Trials Network for HIV/AIDS Interventions. Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men. Papillomavirus Res. 2019 Jun;7:52-61. doi: 10.1016/j.pvr.2019.01.002. Epub 2019 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gardasil	Vaccine	—	—

Indications