TY - JOUR
T1 - High baseline anal human papillomavirus and abnormal anal cytology in a phase 3 trial of the quadrivalent human papillomavirus vaccine in human immunodeficiency virus-infected individuals older than 26 years
T2 - ACTG 5298
AU - Cranston, Ross D.
AU - Cespedes, Michelle S.
AU - Paczuski, Pawel
AU - Yang, Ming
AU - Coombs, Robert W.
AU - Dragavon, Joan
AU - Saah, Alfred
AU - Godfrey, Catherine
AU - Webster-Cyriaque, Jennifer Y.
AU - Chiao, Elizabeth Y.
AU - Bastow, Barbara
AU - Wilkin, Timothy
N1 - Funding Information:
Source of Funding: This research was supported by the NIH Cooperative Agreement U01AI068636 from the NIAID & the NIDCR; U01 AI068634 for the ACTG Statistical & Data Management Center; and ACTG Network Laboratory Grant UM1 AI106701 and P30 AI027757. Merck supplied vaccine, placebo, and serology data analyses and funding for oral HPV DNA assays.
Funding Information:
Conflict of Interest: R.D.C. has received institutional grant support from Merck and Co. T.W. has received institutional grant support from Gilead, BMS and GlaxoSmithKline/ViiV, and consulting support from GlaxoSmithKline/ViiV. M Cespedes has received institutional grant support from GlaxoSmithKline and consulting support from Gilead.
Funding Information:
Janice Fritsche MS APRN PMHNP-BC—Rush University Medical Center CRS (site 2702) grant U01 AI069471, Michael Klebert RN PhD and Teresa Spitz RN—Washington University in St Louis CRS (site 2101) grant AI 69439, Sherrie Wolfe—Northwestern University CRS (site 2701) grant 2UM1 AI069471, Roberto C Arduino MD and Maria Laura Martinez—Houston AIDS Research Team (HART) CRS (site 31473) grant 2 UM1 AI069503, Sandra Valle PA-C – Stanford CRS (site 501) grant AI069556, Annie Luetkemeyer MD and Jay Dwyer RN—UCSF AIDS CRS (site 801) CTU grant 5UM1AI069496, Michelle Saemann RN BSN—University of Cincinnati (site 2401) grant UM1AI068636, Sigrid Perez MD—University Puerto Rico ACTG CRS (site 5401) grant 5UM1AI069415-10, Weill Cornell Uptown CRS (site 7803) grant 5UM1 AI069419, NIH/ NCATS UL1 TR000457, Denver Public Health (site 31470) grant 2 UM1 AI069503, Dr Ronald Mitsuyasu MD and Arezou Sadighi—UCLA Care Center CRS (site 601) grant AI069424, Helen Patterson—The Miriam Hospital CRS (site 2951) grant 5UM1AI069412, Ioana Bica MD—Boston Medical Center (site 104) grant 5U01A1069472, Mary Albrecht MD—Beth Israel Deaconess (Partners/Harvard) CRS (site 103) grant UM1 AI069472-08. Research reported in this publication was supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number UM1 AI068634, UM1 AI068636 and UM1 AI106701. The Study was also supported in part by the Oral HIV AIDS Research Alliance (OHARA), funded by the National Institute of Dental and Craniofacial Research of the National Institutes of Health under Award Number 1U01AI068636. We would additionally like to acknowledge Qinghua Feng, Donna Kenny and Linda Deng for technical support. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The NCT number is NCT01461096.
Funding Information:
Approval was obtained from the AIDS Clinical Trials Group (ACTG) Scientific Agenda Steering Committee, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS, and institutional review board or ethics committees at each participating clinical research site. Written informed consent was obtained from each study participant (ClinicalTrials. gov number NCT01461096).
Publisher Copyright:
Copyright © 2018 by the American Sexually Transmitted Diseases Association. Unauthorized reproduction of this article is prohibited.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Background The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women aged 9 to 26 years to prevent HPV associated anogenital high-grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in human immunodeficiency virus (HIV)-infected men who have sex with men, and women of qHPV to prevent persistent anal HPV infection. Baseline data are presented here. Methods Human immunodeficiency virus-infected men who have sex with men, and women 27 years or older without previous anogenital or oral cancer were enrolled. Baseline anal cytology, high-resolution anoscopy and collection of anal, oral, and vaginal specimens for HPV genotyping were performed and acceptability assessed. Results Five hundred seventy-five (575) participants were enrolled (82% men and 18% women). Median age was 47 years. Race/ethnicity was 46% white, 31% black, and 20% Hispanic. Plasma HIV-1 RNA was less than 50 copies/mL in 83% and median CD4 T count was 602 cells/μL. Abnormal anal cytology was detected in 62%, with corresponding HSIL on biopsy (bHSIL) in 33%. Anal HPV 6, 11, 16, and 18 were detected in 25%, 13%, 32%, and 18% of the participants, respectively. Prevalence of 0, 1, 2, 3, and 4 qHPV types was 40%, 38%, 17%, 4%, and 1%, respectively. Oral infection with 1 or more qHPV type was detected in 10% of the participants. Study procedures were generally acceptable. Conclusions At study baseline, there was a high prevalence of abnormal anal cytology, bHSIL, and HPV infection. Sixty percent of the participants had anal infection with preventable qHPV types.
AB - Background The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women aged 9 to 26 years to prevent HPV associated anogenital high-grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in human immunodeficiency virus (HIV)-infected men who have sex with men, and women of qHPV to prevent persistent anal HPV infection. Baseline data are presented here. Methods Human immunodeficiency virus-infected men who have sex with men, and women 27 years or older without previous anogenital or oral cancer were enrolled. Baseline anal cytology, high-resolution anoscopy and collection of anal, oral, and vaginal specimens for HPV genotyping were performed and acceptability assessed. Results Five hundred seventy-five (575) participants were enrolled (82% men and 18% women). Median age was 47 years. Race/ethnicity was 46% white, 31% black, and 20% Hispanic. Plasma HIV-1 RNA was less than 50 copies/mL in 83% and median CD4 T count was 602 cells/μL. Abnormal anal cytology was detected in 62%, with corresponding HSIL on biopsy (bHSIL) in 33%. Anal HPV 6, 11, 16, and 18 were detected in 25%, 13%, 32%, and 18% of the participants, respectively. Prevalence of 0, 1, 2, 3, and 4 qHPV types was 40%, 38%, 17%, 4%, and 1%, respectively. Oral infection with 1 or more qHPV type was detected in 10% of the participants. Study procedures were generally acceptable. Conclusions At study baseline, there was a high prevalence of abnormal anal cytology, bHSIL, and HPV infection. Sixty percent of the participants had anal infection with preventable qHPV types.
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U2 - 10.1097/OLQ.0000000000000745
DO - 10.1097/OLQ.0000000000000745
M3 - Article
C2 - 29528986
AN - SCOPUS:85044224418
SN - 0148-5717
VL - 45
SP - 266
EP - 271
JO - Sexually transmitted diseases
JF - Sexually transmitted diseases
IS - 4
ER -