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Published in: AIDS and Behavior 1/2011

01-04-2011 | Original Paper

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

Author: Ian McGowan

Published in: AIDS and Behavior | Special Issue 1/2011

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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.
Literature
1.
go back to reference McGowan I. Microbicides for HIV prevention: reality or hope? Curr Opin Infect Dis. 2010;23(1):26–31.PubMedCrossRef McGowan I. Microbicides for HIV prevention: reality or hope? Curr Opin Infect Dis. 2010;23(1):26–31.PubMedCrossRef
2.
go back to reference Stein ZA. HIV prevention: the need for methods women can use. Am J Public Health. 1990;80(4):460–2.PubMedCrossRef Stein ZA. HIV prevention: the need for methods women can use. Am J Public Health. 1990;80(4):460–2.PubMedCrossRef
3.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
4.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
5.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
6.
go back to reference 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 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
7.
go back to reference 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 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
8.
go back to reference 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). 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
10.
go back to reference Karim SS, Ramjee G. Anal sex and HIV transmission in women. Am J Public Health. 1998;88(8):1265–6.PubMedCrossRef Karim SS, Ramjee G. Anal sex and HIV transmission in women. Am J Public Health. 1998;88(8):1265–6.PubMedCrossRef
11.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
12.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
13.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
14.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
15.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
16.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
17.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
18.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
20.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
21.
go back to reference 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.CrossRef 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.CrossRef
22.
go back to reference 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. 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.
23.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
24.
go back to reference 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). 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
26.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
27.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
28.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
30.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
31.
go back to reference Severy L, Newcomer S. Critical issues in contraceptive and STI acceptability research. J Soc Issues. 2005;61(1):45–65.CrossRef Severy L, Newcomer S. Critical issues in contraceptive and STI acceptability research. J Soc Issues. 2005;61(1):45–65.CrossRef
32.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
33.
go back to reference Morrow KM, Ruiz MS. Assessing microbicide acceptability: a comprehensive and integrated approach. AIDS Behav. 2008;12(2):272–83.PubMedCrossRef Morrow KM, Ruiz MS. Assessing microbicide acceptability: a comprehensive and integrated approach. AIDS Behav. 2008;12(2):272–83.PubMedCrossRef
34.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
35.
go back to reference 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.CrossRef 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.CrossRef
36.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
37.
go back to reference 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.CrossRef 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.CrossRef
38.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
39.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
40.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
41.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
42.
go back to reference 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 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
43.
go back to reference 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. 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
45.
go back to reference 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). 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.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
47.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
Metadata
Title
Rectal Microbicides: Can We Make Them and Will People Use Them?
Author
Ian McGowan
Publication date
01-04-2011
Publisher
Springer US
Published in
AIDS and Behavior / Issue Special Issue 1/2011
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI
https://doi.org/10.1007/s10461-011-9899-9

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