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Rectal Microbicides: Can We Make Them and Will People Use Them?

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Abstract

The results of the CAPRISA 004 and iPrEx HIV prevention studies have demonstrated that topical or systemic use of antiretroviral agents can significantly reduce the risk of HIV acquisition associated with unprotected vaginal or anal sexual intercourse. However, the effect size in these studies was relatively modest and product adherence was generally poor. These observations suggest the need for new approaches to HIV prevention, especially for high risk MSM. Rates of lubricant use are high in MSM practicing receptive anal sex. Consequently, the development of an antiretroviral rectal microbicide gel may provide a safe and effective means of preventing HIV infection with an intervention that is likely to have high acceptability among the target population. The purpose of this article is to describe the challenges and progress in the development of rectal microbicides for HIV prevention.

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References

  1. McGowan I. Microbicides for HIV prevention: reality or hope? Curr Opin Infect Dis. 2010;23(1):26–31.

    Article  PubMed  CAS  Google Scholar 

  2. Stein ZA. HIV prevention: the need for methods women can use. Am J Public Health. 1990;80(4):460–2.

    Article  PubMed  CAS  Google Scholar 

  3. Carlos JA, Bingham TA, Stueve A, et al. The role of peer support on condom use among Black and Latino MSM in three urban areas. AIDS Educ Prev. 2010;22(5):430–44.

    Article  PubMed  Google Scholar 

  4. Gorbach PM, Manhart LE, Hess KL, Stoner BP, Martin DH, Holmes KK. Anal intercourse among young heterosexuals in three sexually transmitted disease clinics in the United States. Sex Transm Dis. 2009;36(4):193–8.

    Article  PubMed  Google Scholar 

  5. Beyrer C. Global prevention of HIV infection for neglected populations: men who have sex with men. Clin Infect Dis. 2010;50(Suppl 3):S108–13.

    Article  PubMed  Google Scholar 

  6. Leynaert B, Downs AM, de Vincenzi I. Heterosexual transmission of human immunodeficiency virus: variability of infectivity throughout the course of infection. European Study Group on Heterosexual Transmission of HIV. Am J Epidemiol. 1998;148(1):88–96.

    PubMed  CAS  Google Scholar 

  7. Vittinghoff E, Douglas J, Judson F, McKirnan D, MacQueen K, Buchbinder SP. Per-contact risk of human immunodeficiency virus transmission between male sexual partners. Am J Epidemiol. 1999;150(3):306–11.

    PubMed  CAS  Google Scholar 

  8. Mosher WD, Chandra A, Jones J. Sexual behavior and selected health measures: men and women 15– 44 years of age, United States, 2002. Hyattsville, MD: National Center for Health Statistics; 2005 (Sep 15. Report No.: 362).

  9. Misegades L, Page-Shafer K, Halperin D, McFarland W. Anal intercourse among young low-income women in California: an overlooked risk factor for HIV? AIDS. 2001;15(4):534–5.

    Article  PubMed  CAS  Google Scholar 

  10. Karim SS, Ramjee G. Anal sex and HIV transmission in women. Am J Public Health. 1998;88(8):1265–6.

    Article  PubMed  CAS  Google Scholar 

  11. Lane T, Pettifor A, Pascoe S, Fiamma A, Rees H. Heterosexual anal intercourse increases risk of HIV infection among young South African men. AIDS. 2006;20(1):123–5.

    Article  PubMed  Google Scholar 

  12. Kalichman S, Simbayi L, Cain D, Jooste S. Heterosexual anal intercourse among community and clinical settings in Cape Town, South Africa. Sex Transm Infect. 2009;85(6):411–5.

    Article  PubMed  CAS  Google Scholar 

  13. Baral S, Trapence G, Motimedi F, et al. HIV prevalence, risks for HIV infection, and human rights among men who have sex with men (MSM) in Malawi, Namibia, and Botswana. PLoS ONE. 2009;4(3):e4997.

    Article  PubMed  Google Scholar 

  14. Baral S, Sifakis F, Cleghorn F, Beyrer C. Elevated risk for HIV infection among men who have sex with men in low- and middle-income countries 2000–2006: a systematic review. PLoS Med. 2007;4(12):e339.

    Article  PubMed  Google Scholar 

  15. Carballo-Dieguez A, Stein Z, Saez H, Dolezal C, Nieves-Rosa L, Diaz F. Frequent use of lubricants for anal sex among men who have sex with men: the HIV prevention potential of a microbicidal gel. Am J Public Health. 2000;90(7):1117–21.

    Article  PubMed  CAS  Google Scholar 

  16. Gross M, Buchbinder SP, Celum C, Heagerty P, Seage GR III. Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team. Sex Transm Dis. 1998;25(6):296–302.

    Article  PubMed  CAS  Google Scholar 

  17. Carballo-Dieguez A, O’sullivan LF, Lin P, Dolezal C, Pollack L, Catania J. Awareness and attitudes regarding microbicides and nonoxynol-9 use in a probability sample of gay men. AIDS Behav. 2007;11(2):271–6.

    Article  PubMed  Google Scholar 

  18. Nodin N, Carballo-Dieguez A, Ventuneac AM, Balan IC, Remien R. Knowledge and acceptability of alternative HIV prevention bio-medical products among MSM who bareback. AIDS Care. 2008;20(1):106–15.

    Article  PubMed  CAS  Google Scholar 

  19. Berg RC. Barebacking: a review of the literature. Arch Sex Behav. 2009;38(5):754–64.

    Article  PubMed  Google Scholar 

  20. Van Damme L, Ramjee G, Alary M, et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial. Lancet. 2002;360(9338):971–7.

    Article  PubMed  Google Scholar 

  21. Karim QA, Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.

    Article  Google Scholar 

  22. Tabet SR, Surawicz C, Horton S, et al. Safety and toxicity of nonoxynol-9 gel as a rectal microbicide. Sex Transm Infect. 1999;26(10):564–71.

    CAS  Google Scholar 

  23. McGowan I, Elliott J, Cortina G, et al. Characterization of baseline intestinal mucosal indices of injury and inflammation in men for use in rectal microbicide trials (HIV Prevention Trials Network-056). J Acquir Immune Defic Syndr. 2007;46(4):417–25.

    Article  PubMed  Google Scholar 

  24. Anton P, Adler A, Khanukova E, et al. A Phase 1 rectal safety and acceptability study of UC781 microbicide gel. In: 16th Conference on Retroviruses and opportunistic infections, Montreal, 2009 (abstract 1066).

  25. Fuchs EJ, Lee LA, Torbenson MS, et al. Hyperosmolar sexual lubricant causes epithelial damage in the distal colon: potential implication for HIV transmission. J Infect Dis. 2007;195(5):703–10.

    Article  PubMed  Google Scholar 

  26. Barnhart KT, Pretorius ES, Timbers K, Shera D, Shabbout M, Malamud D. In vivo distribution of a vaginal gel: MRI evaluation of the effects of gel volume, time and simulated intercourse. Contraception. 2004;70(6):498–505.

    Article  PubMed  CAS  Google Scholar 

  27. Barnhart K, Kulp JL, Rosen M, Shera DM. A randomized trial to determine the distribution of four topical gel formulations in the human vagina. Contraception. 2009;79(4):297–303.

    Article  PubMed  CAS  Google Scholar 

  28. Hendrix CW, Fuchs EJ, Macura KJ, Lee LA, Parsons TL, Bakshi RP, et al. Quantitative imaging and sigmoidoscopy to assess distribution of rectal microbicide surrogates. Clin Pharmacol Ther. 2008;83(1):97–105.

    Article  PubMed  CAS  Google Scholar 

  29. UNAIDS. Ethical considerations in biomedical HIV prevention trials. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2007. http://data.unaids.org/pub/Report/2007/jc1399_ethical_considerations_en.pdf. Accessed 31 Oct 2010.

  30. Elias C, Coggins C. Acceptability research on female-controlled barrier methods to prevent heterosexual transmission of HIV: Where have we been? Where are we going? J Womens Health Gend Based Med. 2001;10(2):163–73.

    Article  PubMed  CAS  Google Scholar 

  31. Severy L, Newcomer S. Critical issues in contraceptive and STI acceptability research. J Soc Issues. 2005;61(1):45–65.

    Article  Google Scholar 

  32. Mantell JE, Myer L, Carballo-Dieguez A, Stein Z, Ramjee G, Morar NS, et al. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005;60(2):319–30.

    Article  PubMed  Google Scholar 

  33. Morrow KM, Ruiz MS. Assessing microbicide acceptability: a comprehensive and integrated approach. AIDS Behav. 2008;12(2):272–83.

    Article  PubMed  Google Scholar 

  34. Tolley EE, Severy LJ. Integrating behavioral and social science research into microbicide clinical trials: challenges and opportunities. Am J Public Health. 2006;96(1):79–83.

    Article  PubMed  Google Scholar 

  35. Rosen RK, Morrow KM, Carballo-Dieguez A, et al. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008;17(3):383–92.

    Article  Google Scholar 

  36. Bentley ME, Morrow KM, Fullem A, et al. Acceptability of a novel vaginal microbicide during a safety trial among low-risk women. Fam Plann Perspect. 2000;32(4):184–8.

    Article  PubMed  CAS  Google Scholar 

  37. Morrow K, Rosen R, Richter L, et al. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. J Womens Health (Larchmt). 2003;12(7):655–66.

    Article  Google Scholar 

  38. El-Sadr WM, Mayer KH, Maslankowski L, et al. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS. 2006;20(8):1109–16.

    Article  PubMed  CAS  Google Scholar 

  39. Carballo-Dieguez A, Exner T, Dolezal C, Pickard R, Lin P, Mayer KH. Rectal microbicide acceptability: results of a volume escalation trial. Sex Transm Dis. 2007;34(4):224–9.

    Article  PubMed  Google Scholar 

  40. Carballo-Dieguez A, Dolezal C, Bauermeister JA, O’Brien W, Ventuneac A, Mayer K. Preference for gel over suppository as delivery vehicle for a rectal microbicide: results of a randomised, crossover acceptability trial among men who have sex with men. Sex Transm Infect. 2008;84(6):483–7.

    Article  PubMed  CAS  Google Scholar 

  41. Ventuneac A, Carballo-Dieguez A, McGowan I, et al. Acceptability of UC781 gel as a rectal microbicide among HIV-uninfected women and men. AIDS Behav. 2010;14(3):618–28.

    Article  PubMed  Google Scholar 

  42. Rudy BJ, Kapogiannis BG, Lally MA, et al. Youth-specific considerations in the development of preexposure prophylaxis, microbicide, and vaccine research trials. J Acquir Immune Defic Syndr. 2010;54(Suppl 1):S31–42.

    PubMed  Google Scholar 

  43. van Griensven F, de Lind van Wijngaarden JW, Baral S, Grulich A. The global epidemic of HIV infection among men who have sex with men. Curr Opin HIV AIDS. 2009 Jul;4(4):300–7.

  44. Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, et al. Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand. N Engl J Med. 2009;361:2209–20.

    Article  PubMed  CAS  Google Scholar 

  45. Elliott J, McGowan I, Adler A, et al. Strong suppression of HIV-1 infection of colorectal explants following in vivo rectal application of UC781 gel: a novel endpoint in a Phase I trial. In: 16th Conference on Retroviruses and opportunistic infections, Montreal, 2009 (abstract 1067).

  46. Sifakis F, Hylton JB, Flynn C, et al. Racial disparities in HIV incidence among young men who have sex with men: the Baltimore Young Men’s Survey. J Acquir Immune Defic Syndr. 2007;46(3):343–8.

    Article  PubMed  Google Scholar 

  47. Sifakis F, Hylton JB, Flynn C, et al. Prevalence of HIV infection and prior HIV testing among young men who have sex with men. The Baltimore young men’s survey. AIDS Behav. 2010;14(4):904–12.

    Article  PubMed  Google Scholar 

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Acknowledgments

Dr. McGowan gratefully acknowledges funding from the United States National Institutes of Health to support his research in microbicide development including this review article (5U19AI060614, 5U01AI066734, and 1R01HD059533).

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  1. Department of Medicine, Division of Gastroenterology, Haepatology, and Nutrition, University of Pittsburgh School of Medicine, 204 Craft Ave., Room B505, Pittsburgh, PA, 15213, USA

    Ian McGowan

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Correspondence to Ian McGowan.

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McGowan, I. Rectal Microbicides: Can We Make Them and Will People Use Them?. AIDS Behav 15 (Suppl 1), 66–71 (2011). https://doi.org/10.1007/s10461-011-9899-9

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