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The effectiveness of Carraguard, a vaginal microbicide, in protecting women against high-risk human papillomavirus infection.
Antivir Ther. 2011; 16(8):1219-26.AT

Abstract

BACKGROUND

A randomised, double-blind, placebo-controlled trial found the vaginal microbicide Carraguard unable to prevent HIV infection. A substudy assessed the association of genital high-risk human papillomavirus (HR-HPV) in women at study end with Carraguard use.

METHODS

Participants received Carraguard gel or placebo plus condoms, and were instructed to use gel plus condoms during each act of vaginal intercourse. HR-HPV detection on cervical samples from 1,723 women was by Digene Hybrid Capture 2 analysis. Poisson regression analysis assessed the prevalence of genital HR-HPV for individuals receiving Carraguard relative to individuals receiving placebo.

RESULTS

In the Carraguard arm (n=875) the end trial unadjusted HR-HPV prevalence was 23.5% (95% CI 20.8-26.3) and 23.0% (95% CI 20.2-25.8) in placebo arm (n=843). Significant risk factors for HR-HPV infection were younger age, being single, an abnormal pap smear, multiple sexual partners and promiscuous behaviour without the use of a condom. There were 348 compliant women (174 Carraguard, 174 placebo users), with relatively high adherence to gel use, who inserted 80% of their opened, returned applicators of test product with the proportion of applicator insertions to sex acts >30%. After adjusting for risk factors, these compliant Carraguard users were 0.62 as likely to be classified HR-HPV positive (95% CI 0.41-0.94) as compliant placebo users.

CONCLUSIONS

The prevalence of HR-HPV infection was lower in compliant Carraguard users than compliant placebo users. To our knowledge, this is the first report showing a negative association of HPV infection with a vaginal microbicide.

Authors+Show Affiliations

Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

22155903

Citation

Marais, Dianne, et al. "The Effectiveness of Carraguard, a Vaginal Microbicide, in Protecting Women Against High-risk Human Papillomavirus Infection." Antiviral Therapy, vol. 16, no. 8, 2011, pp. 1219-26.
Marais D, Gawarecki D, Allan B, et al. The effectiveness of Carraguard, a vaginal microbicide, in protecting women against high-risk human papillomavirus infection. Antivir Ther. 2011;16(8):1219-26.
Marais, D., Gawarecki, D., Allan, B., Ahmed, K., Altini, L., Cassim, N., Gopolang, F., Hoffman, M., Ramjee, G., & Williamson, A. L. (2011). The effectiveness of Carraguard, a vaginal microbicide, in protecting women against high-risk human papillomavirus infection. Antiviral Therapy, 16(8), 1219-26. https://doi.org/10.3851/IMP1890
Marais D, et al. The Effectiveness of Carraguard, a Vaginal Microbicide, in Protecting Women Against High-risk Human Papillomavirus Infection. Antivir Ther. 2011;16(8):1219-26. PubMed PMID: 22155903.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effectiveness of Carraguard, a vaginal microbicide, in protecting women against high-risk human papillomavirus infection. AU - Marais,Dianne, AU - Gawarecki,Daniel, AU - Allan,Bruce, AU - Ahmed,Khatija, AU - Altini,Lydia, AU - Cassim,Nazira, AU - Gopolang,Felicity, AU - Hoffman,Margaret, AU - Ramjee,Gita, AU - Williamson,Anna-Lise, PY - 2011/12/14/entrez PY - 2011/12/14/pubmed PY - 2012/4/3/medline SP - 1219 EP - 26 JF - Antiviral therapy JO - Antivir Ther VL - 16 IS - 8 N2 - BACKGROUND: A randomised, double-blind, placebo-controlled trial found the vaginal microbicide Carraguard unable to prevent HIV infection. A substudy assessed the association of genital high-risk human papillomavirus (HR-HPV) in women at study end with Carraguard use. METHODS: Participants received Carraguard gel or placebo plus condoms, and were instructed to use gel plus condoms during each act of vaginal intercourse. HR-HPV detection on cervical samples from 1,723 women was by Digene Hybrid Capture 2 analysis. Poisson regression analysis assessed the prevalence of genital HR-HPV for individuals receiving Carraguard relative to individuals receiving placebo. RESULTS: In the Carraguard arm (n=875) the end trial unadjusted HR-HPV prevalence was 23.5% (95% CI 20.8-26.3) and 23.0% (95% CI 20.2-25.8) in placebo arm (n=843). Significant risk factors for HR-HPV infection were younger age, being single, an abnormal pap smear, multiple sexual partners and promiscuous behaviour without the use of a condom. There were 348 compliant women (174 Carraguard, 174 placebo users), with relatively high adherence to gel use, who inserted 80% of their opened, returned applicators of test product with the proportion of applicator insertions to sex acts >30%. After adjusting for risk factors, these compliant Carraguard users were 0.62 as likely to be classified HR-HPV positive (95% CI 0.41-0.94) as compliant placebo users. CONCLUSIONS: The prevalence of HR-HPV infection was lower in compliant Carraguard users than compliant placebo users. To our knowledge, this is the first report showing a negative association of HPV infection with a vaginal microbicide. SN - 2040-2058 UR - https://www.unboundmedicine.com/medline/citation/22155903/The_effectiveness_of_Carraguard_a_vaginal_microbicide_in_protecting_women_against_high_risk_human_papillomavirus_infection_ DB - PRIME DP - Unbound Medicine ER -