- Shattock RJ, Moore JP. Inhibiting sexual transmission of HIV-1 infection. Nat Rev Microbiol. 2003;1(1):25-34.
- Shattock RJ, Rosenberg Z. Microbicides: topical prevention against HIV. Cold Spring Harb Perspect Med. 2012;2(2):a007385.
- Weller S, Davis K. Condom effectiveness in reducing heterosexual HIV transmission. Cochrane Database Syst Rev. 2002(1):CD003255.
- McGowan I. The development of rectal microbicides for HIV prevention. Expert Opin Drug Deliv. 2014;11(1):69-82.
- Riddell Jt, Amico KR, Mayer KH. HIV Preexposure Prophylaxis: A Review. JAMA. 2018;319(12):1261-8.
- Romano J, Malcolm RK, Garg S, Rohan LC, Kaptur PE. Microbicide delivery: formulation technologies and strategies. Curr Opin HIV AIDS. 2008;3(5):558-66.
- Deutsch MB, Glidden DV, Sevelius J, Keatley J, McMahan V, Guanira J, et al. HIV pre-exposure prophylaxis in transgender women: a subgroup analysis of the iPrEx trial. Lancet HIV. 2015;2(12):e512-9.
- Chandra A, Mosher WD, Copen C, Sionean C. Sexual behavior, sexual attraction, and sexual identity in the United States: data from the 2006-2008 National Survey of Family Growth. Natl Health Stat Report. 2011(36):1-36.
- UNAIDS Fact sheet 2018 [press release].
- Ward J, McManus H, McGregor S, Hawke K, Giele C, J-Y. S, et al. HIV incidence in indigenous and non-indigenous populations in Australia: a population-level observational study. 2018;Lancet HIV.
- Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, et al. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016;375(22):2133-43.
- Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med. 2016;375(22):2121-32.
- Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-99.
- Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410.
- Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423-34.
- Molina JM, Charreau I, Spire B, Cotte L, Chas J, Capitant C, et al. Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study. Lancet HIV. 2017;4(9):e402-e10.
- McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60.
- Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet Infect Dis. 2014;14(9):820-9.
- Wright E, Grulich A, Roy K, Boyd M, Cornelisse V, Russell D, et al. Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine HIV pre-exposure prophylaxis: clinical guidelines. Update April 2018. J Virus Erad. 2018;4(3):143-59.
- Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509-18.
- Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411-22.
- Abdool Karim SS, Passmore JS, Baxter C. The microbiome and HIV prevention strategies in women. Curr Opin HIV AIDS. 2018;13(1):81-7.
- Janes H, Corey L, Ramjee G, Carpp LN, Lombard C, Cohen MS, et al. Weighing the Evidence of Efficacy of Oral PrEP for HIV Prevention in Women in Southern Africa. AIDS Res Hum Retroviruses. 2018;34(8):645-56.
- Patterson KB, Prince HA, Kraft E, Jenkins AJ, Shaheen NJ, Rooney JF, et al. Penetration of tenofovir and emtricitabine in mucosal tissues: implications for prevention of HIV-1 transmission. Sci Transl Med. 2011;3(112):112re4.
- Marrazzo JM. HIV Prevention: Opportunities and Challenges. Top Antivir Med. 2017;24(4):123-6.
- Barrett SE, Teller RS, Forster SP, Li L, Mackey MA, Skomski D, et al. Extended Duration MK-8591-Eluting Implant as a Candidate for HIV Treatment and Prevention. Antimicrob Agents Chemother. 2018.
- Friend DR. An update on multipurpose prevention technologies for the prevention of HIV transmission and pregnancy. Expert Opin Drug Deliv. 2016;13(4):533-45.
- Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007;369(9563):787-97.
- Fichorova RN, Tucker LD, Anderson DJ. The molecular basis of nonoxynol-9-induced vaginal inflammation and its possible relevance to human immunodeficiency virus type 1 transmission. J Infect Dis. 2001;184(4):418-28.
- Cone RA, Hoen T, Wong X, Abusuwwa R, Anderson DJ, Moench TR. Vaginal microbicides: detecting toxicities in vivo that paradoxically increase pathogen transmission. BMC Infect Dis. 2006;6:90.
- Van Damme L, Ramjee G, Alary M, Vuylsteke B, Chandeying V, Rees H, 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.
- Peterson L, Nanda K, Opoku BK, Ampofo WK, Owusu-Amoako M, Boakye AY, et al. SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana. PLoS One. 2007;2(12):e1312.
- Feldblum PJ, Adeiga A, Bakare R, Wevill S, Lendvay A, Obadaki F, et al. SAVVY vaginal gel (C31G) for prevention of HIV infection: a randomized controlled trial in Nigeria. PLoS One. 2008;3(1):e1474.
- Mayer KH, Peipert J, Fleming T, Fullem A, Moench T, Cu-Uvin S, et al. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis. 2001;32(3):476-82.
- Amaral E, Faundes A, Zaneveld L, Waller D, Garg S. Study of the vaginal tolerance to Acidform, an acid-buffering, bioadhesive gel. Contraception. 1999;60(6):361-6.
- Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, Chirenje ZM, Taha T, et al. Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women. AIDS. 2011;25(7):957-66.
- O’Hanlon DE, Moench TR, Cone RA. Vaginal pH and microbicidal lactic acid when lactobacilli dominate the microbiota. PLoS One. 2013;8(11):e80074.
- Tyssen D, Wang YY, Hayward JA, Agius PA, DeLong K, Aldunate M, et al. Anti-HIV-1 Activity of Lactic Acid in Human Cervicovaginal Fluid. mSphere. 2018;3(4).
- Aldunate M, Tyssen D, Johnson A, Zakir T, Sonza S, Moench T, et al. Vaginal concentrations of lactic acid potently inactivate HIV. J Antimicrob Chemother. 2013;68(9):2015-25.
- Tachedjian G, Aldunate M, Bradshaw CS, Cone RA. The role of lactic acid production by probiotic Lactobacillus species in vaginal health. Res Microbiol. 2017;168(9-10):782-92.
- von Mollendorf CE, Van Damme L, Moyes JA, Rees VH, Callahan MM, Mauck CK, et al. Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y Jelly. Contraception. 2010;81(3):232-9.
- Moulard M, Lortat-Jacob H, Mondor I, Roca G, Wyatt R, Sodroski J, et al. Selective interactions of polyanions with basic surfaces on human immunodeficiency virus type 1 gp120. J Virol. 2000;74(4):1948-60.
- Scordi-Bello IA, Mosoian A, He C, Chen Y, Cheng Y, Jarvis GA, et al. Candidate sulfonated and sulfated topical microbicides: comparison of anti-human immunodeficiency virus activities and mechanisms of action. Antimicrob Agents Chemother. 2005;49(9):3607-15.
- Fletcher PS, Wallace GS, Mesquita PM, Shattock RJ. Candidate polyanion microbicides inhibit HIV-1 infection and dissemination pathways in human cervical explants. Retrovirology. 2006;3:46.
- Salazar-Gonzalez JF, Salazar MG, Keele BF, Learn GH, Giorgi EE, Li H, et al. Genetic identity, biological phenotype, and evolutionary pathways of transmitted/founder viruses in acute and early HIV-1 infection. J Exp Med. 2009;206(6):1273-89.
- Van Damme L, Govinden R, Mirembe FM, Guedou F, Solomon S, Becker ML, et al. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med. 2008;359(5):463-72.
- Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plagianos MG, Friedland B, et al. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;372(9654):1977-87.
- McCormack S, Ramjee G, Kamali A, Rees H, Crook AM, Gafos M, et al. PRO2000 vaginal gel for prevention of HIV-1 infection (Microbicides Development Programme 301): a phase 3, randomised, double-blind, parallel-group trial. Lancet. 2010;376(9749):1329-37.
- Neurath AR, Strick N, Li YY. Role of seminal plasma in the anti-HIV-1 activity of candidate microbicides. BMC Infect Dis. 2006;6:150.
- Keller MJ, Mesquita PM, Torres NM, Cho S, Shust G, Madan RP, et al. Postcoital bioavailability and antiviral activity of 0.5% PRO 2000 gel: implications for future microbicide clinical trials. PLoS One. 2010;5(1):e8781.
- Tyssen D, Henderson SA, Johnson A, Sterjovski J, Moore K, La J, et al. Structure activity relationship of dendrimer microbicides with dual action antiviral activity. PLoS One. 2010;5(8):e12309.
- Rupp R, Rosenthal SL, Stanberry LR. VivaGel (SPL7013 Gel): a candidate dendrimer–microbicide for the prevention of HIV and HSV infection. Int J Nanomedicine. 2007;2(4):561-6.
- Chen MY, Millwood IY, Wand H, Poynten M, Law M, Kaldor JM, et al. A randomized controlled trial of the safety of candidate microbicide SPL7013 gel when applied to the penis. J Acquir Immune Defic Syndr. 2009;50(4):375-80.
- Price CF, Tyssen D, Sonza S, Davie A, Evans S, Lewis GR, et al. SPL7013 Gel (VivaGel(R)) retains potent HIV-1 and HSV-2 inhibitory activity following vaginal administration in humans. PLoS One. 2011;6(9):e24095.
- O’Loughlin J, Millwood IY, McDonald HM, Price CF, Kaldor JM, Paull JR. Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study. Sex Transm Dis. 2010;37(2):100-4.
- McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, et al. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011;25(8):1057-64.
- Carballo-Dieguez A, Giguere R, Dolezal C, Chen BA, Kahn J, Zimet G, et al. “Tell Juliana”: acceptability of the candidate microbicide VivaGel(R) and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study. AIDS Behav. 2012;16(7):1761-74.
- Rosenthal SL, Holmes W, Maher L. Australian men’s experiences during a microbicide male tolerance study. AIDS Care. 2009;21(1):125-30.
- Cohen CR, Brown J, Moscicki AB, Bukusi EA, Paull JR, Price CF, et al. A phase I randomized placebo controlled trial of the safety of 3% SPL7013 Gel (VivaGel(R)) in healthy young women administered twice daily for 14 days. PLoS One. 2011;6(1):e16258.
- Holmes WR, Maher L, Rosenthal SL. Attitudes of men in an Australian male tolerance study towards microbicide use. Sex Health. 2008;5(3):273-8.
- Grant RM, Hamer D, Hope T, Johnston R, Lange J, Lederman MM, et al. Whither or wither microbicides? Science. 2008;321(5888):532-4.
- das Neves J, Nunes R, Rodrigues F, Sarmento B. Nanomedicine in the development of anti-HIV microbicides. Adv Drug Deliv Rev. 2016;103:57-75.
- Rees H, Delaney-Moretlwe SA, Lombard C, Baron D, Pnachia R, Myer L, et al. FACTS 001 Phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. Conference on Retroviruses and Opportuniistic Infections; Seattle, Washington, USA2015.
- McConville C, Boyd P, Major I. Efficacy of Tenofovir 1% Vaginal Gel in Reducing the Risk of HIV-1 and HSV-2 Infection. Clin Med Insights Womens Health. 2014;7:1-8.
- Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, 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.
- Kashuba AD, Gengiah TN, Werner L, Yang KH, White NR, Karim QA, et al. Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in the CAPRISA 004 Trial: Importance of Adherence for Microbicide Effectiveness. J Acquir Immune Defic Syndr. 2015;69(3):264-9.
- Malcolm RK, Boyd PJ, McCoy CF, Murphy DJ. Microbicide vaginal rings: Technological challenges and clinical development. Adv Drug Deliv Rev. 2016;103:33-56.
- Nel A, Bekker LG, Bukusi E, Hellstrm E, Kotze P, Louw C, et al. Safety, Acceptability and Adherence of Dapivirine Vaginal Ring in a Microbicide Clinical Trial Conducted in Multiple Countries in Sub-Saharan Africa. PLoS One. 2016;11(3):e0147743.
- Anderson DJ, Politch JA, Zeitlin L, Hiatt A, Kadasia K, Mayer KH, et al. Systemic and topical use of monoclonal antibodies to prevent the sexual transmission of HIV. AIDS. 2017;31(11):1505-17.
- Veazey RS, Shattock RJ, Pope M, Kirijan JC, Jones J, Hu Q, et al. Prevention of virus transmission to macaque monkeys by a vaginally applied monoclonal antibody to HIV-1 gp120. Nat Med. 2003;9(3):343-6.
- Moog C, Dereuddre-Bosquet N, Teillaud JL, Biedma ME, Holl V, Van Ham G, et al. Protective effect of vaginal application of neutralizing and nonneutralizing inhibitory antibodies against vaginal SHIV challenge in macaques. Mucosal Immunol. 2014;7(1):46-56.
- Burton DR, Hessell AJ, Keele BF, Klasse PJ, Ketas TA, Moldt B, et al. Limited or no protection by weakly or nonneutralizing antibodies against vaginal SHIV challenge of macaques compared with a strongly neutralizing antibody. Proc Natl Acad Sci U S A. 2011;108(27):11181-6.
- Watkins JD, Sholukh AM, Mukhtar MM, Siddappa NB, Lakhashe SK, Kim M, et al. Anti-HIV IgA isotypes: differential virion capture and inhibition of transcytosis are linked to prevention of mucosal R5 SHIV transmission. AIDS. 2013;27(9):F13-20.
- Astronomo RD, Santra S, Ballweber-Fleming L, Westerberg KG, Mach L, Hensley-McBain T, et al. Neutralization Takes Precedence Over IgG or IgA Isotype-related Functions in Mucosal HIV-1 Antibody-mediated Protection. EBioMedicine. 2016;14:97-111.
- Veselinovic M, Neff CP, Mulder LR, Akkina R. Topical gel formulation of broadly neutralizing anti-HIV-1 monoclonal antibody VRC01 confers protection against HIV-1 vaginal challenge in a humanized mouse model. Virology. 2012;432(2):505-10.
- Ma JK, Drossard J, Lewis D, Altmann F, Boyle J, Christou P, et al. Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants. Plant Biotechnol J. 2015;13(8):1106-20.
- Zhao C, Gunawardana M, Villinger F, Baum MM, Remedios-Chan M, Moench TR, et al. Pharmacokinetics and Preliminary Safety of Pod-Intravaginal Rings Delivering the Monoclonal Antibody VRC01-N for HIV Prophylaxis in a Macaque Model. Antimicrob Agents Chemother. 2017;61(7).
- Morris GC, Wiggins RC, Woodhall SC, Bland JM, Taylor CR, Jespers V, et al. MABGEL 1: first phase 1 trial of the anti-HIV-1 monoclonal antibodies 2F5, 4E10 and 2G12 as a vaginal microbicide. PLoS One. 2014;9(12):e116153.
- Kramski M, Center RJ, Wheatley AK, Jacobson JC, Alexander MR, Rawlin G, et al. Hyperimmune bovine colostrum as a low-cost, large-scale source of antibodies with broad neutralizing activity for HIV-1 envelope with potential use in microbicides. Antimicrob Agents Chemother. 2012;56(8):4310-9.
- Sok D, Le KM, Vadnais M, Saye-Francisco KL, Jardine JG, Torres JL, et al. Rapid elicitation of broadly neutralizing antibodies to HIV by immunization in cows. Nature. 2017;548(7665):108-11.
- Kramski M, Lichtfuss GF, Navis M, Isitman G, Wren L, Rawlin G, et al. Anti-HIV-1 antibody-dependent cellular cytotoxicity mediated by hyperimmune bovine colostrum IgG. Eur J Immunol. 2012;42(10):2771-81.
- Heydarchi B, Center RJ, Gonelli C, Muller B, Mackenzie C, Khoury G, et al. Repeated Vaccination of Cows with HIV Env gp140 during Subsequent Pregnancies Elicits and Sustains an Enduring Strong Env-Binding and Neutralising Antibody Response. PLoS One. 2016;11(6):e0157353.
- Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, et al. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006;20(4):543-51.
- Fuchs EJ, Lee LA, Torbenson MS, Parsons TL, Bakshi RP, Guidos AM, 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.
- Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, et al. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One. 2010;5(2):e9310.
- Dezzutti CS, Rohan LC, Wang L, Uranker K, Shetler C, Cost M, et al. Reformulated tenofovir gel for use as a dual compartment microbicide. J Antimicrob Chemother. 2012;67(9):2139-42.
- Cranston RD, Lama JR, Richardson BA, Carballo-Dieguez A, Kunjara Na Ayudhya RP, Liu K, et al. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel. Clin Infect Dis. 2017;64(5):614-20.
- Carballo-Dieguez A, Balan IC, Brown W, 3rd, Giguere R, Dolezal C, Leu CS, et al. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One. 2017;12(7):e0181607.
- Hoang T, Date AA, Ortiz JO, Young TW, Bensouda S, Xiao P, et al. Development of rectal enema as microbicide (DREAM): Preclinical progressive selection of a tenofovir prodrug enema. Eur J Pharm Biopharm. 2018.
- McKinnon LR, Liebenberg LJ, Yende-Zuma N, Archary D, Ngcapu S, Sivro A, et al. Genital inflammation undermines the effectiveness of tenofovir gel in preventing HIV acquisition in women. Nat Med. 2018;24(4):491-6.
- Gosmann C, Anahtar MN, Handley SA, Farcasanu M, Abu-Ali G, Bowman BA, et al. Lactobacillus-Deficient Cervicovaginal Bacterial Communities Are Associated with Increased HIV Acquisition in Young South African Women. Immunity. 2017;46(1):29-37.
- Burgener A, McGowan I, Klatt NR. HIV and mucosal barrier interactions: consequences for transmission and pathogenesis. Curr Opin Immunol. 2015;36:22-30.
- Arnold KB, Burgener A, Birse K, Romas L, Dunphy LJ, Shahabi K, et al. Increased levels of inflammatory cytokines in the female reproductive tract are associated with altered expression of proteases, mucosal barrier proteins, and an influx of HIV-susceptible target cells. Mucosal Immunol. 2016;9(1):194-205.
- Klatt NR, Cheu R, Birse K, Zevin AS, Perner M, Noel-Romas L, et al. Vaginal bacteria modify HIV tenofovir microbicide efficacy in African women. Science. 2017;356(6341):938-45.
- Heffron R, McClelland RS, Balkus JE, Celum C, Cohen CR, Mugo N, et al. Efficacy of oral pre-exposure prophylaxis (PrEP) for HIV among women with abnormal vaginal microbiota: a post-hoc analysis of the randomised, placebo-controlled Partners PrEP Study. Lancet HIV. 2017;4(10):e449-e56.
- Hearps AC, Tyssen D, Srbinovski D, Bayigga L, Diaz DJD, Aldunate M, et al. Vaginal lactic acid elicits an anti-inflammatory response from human cervicovaginal epithelial cells and inhibits production of pro-inflammatory mediators associated with HIV acquisition. Mucosal Immunol. 2017;10(6):1480-90.