ACIDFORM: A review of the evidence

Contraception

Volumn 90, Issue 1, 2014, Pages 11-18

  Bayer, Lisa L ^a   Jensen, Jeffrey T ^a  

^a OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

Acid buffering; Acidifying agent; Microbicide; Spermicide

Indexed keywords

ACIDFORM; MICROBICIDE; SPERMICIDAL AGENT; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; CONTRACEPTIVE AGENT;

BIBLIOGRAPHIC DATABASE; CONTRACEPTIVE BEHAVIOR; DRUG EFFECT; DRUG EFFICACY; DRUG MARKETING; GARDNERELLA VAGINALIS; HUMAN; NEISSERIA GONORRHOEAE; PATIENT SAFETY; PH; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSTCOITAL TEST; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SEXUALLY TRANSMITTED DISEASE; SPERM; SPERMATOZOON; TREATMENT DURATION; UNITED STATES; UNWANTED PREGNANCY; UTERINE CERVIX CAP; UTERINE CERVIX MUCUS; VAGINA DISCHARGE; VAGINA FLORA; VAGINAL LUBRICATION; VISCOSITY; FEMALE; MALE;

ANTI-INFECTIVE AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; CONTRACEPTIVE AGENTS; FEMALE; HUMANS; MALE; SPERMATOCIDAL AGENTS; UNITED STATES;

EID: 84901763074     PISSN: 00107824     EISSN: 18790518     Source Type: Journal    
DOI: 10.1016/j.contraception.2014.01.015     Document Type: Review

References (61)

1. A.M. Minnis, and N.S. Padian Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions Sex Transm Dis 81 2005 193 200
2. T.R. Moench, T. Chipato, and N.S. Padian Preventing disease by protecting the cervix: the unexplored promise of internal vaginal barrier devices AIDS 15 2001 1595 1602
3. L. Speroff, and P.D. Darney A clinical guide for contraception 2006 Lippincott Williams & Wilkins Philadelphia, PA
4. D. Wilkinson, M. Tholandi, G. Ramjee, and G.W. Rutherford Nonoxynol-9 spermicide for prevention of vaginally acquired HIV and other sexually transmitted infections: systematic review and meta-analysis of randomised controlled trials including more than 5000 women Lancet Infect Dis 2 2002 613 617
5. L. Van Damme, G. Ramjee, and M. Alary et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a randomised controlled trial Lancet 360 2002 971 977
6. J.G. Wylie, and A. Henderson Identity and glycogen-fermenting ability of lactobacilli isolated from the vagina of pregnant women J Med Microbiol 2 1969 363 366
7. S. Graves, T. Gotv, and F. Trewartha Effect of pH on the motility and virulence of Treponema pallidum (Nichols) and Treponema paraluis-cuniculi in vitro under anaerobic conditions Br J Vener Dis 56 1980 269
8. C. Kempf, P. Jentsch, and F.B. Barre-Sinoussi et al. Inactivation of human immunodeficiency virus (HIV) by low pH and pepsin J Acquir Immune Defic Syndr 4 1991 828 830
9. E.A. Mahmoud, L.O. Svensson, S.E. Olsson, and P.A. Mardh Antichlamydial activity of vaginal secretion Am J Obstet Gynecol 172 1995 1268 1272
10. E. Nagy, M. Petterson, and P.A. Mardh Antibiosis between bacteria isolated from the vagina of women with and without signs of bacterial vaginosis APMIS 99 1991 739 744
11. T.J. O'Connor, D. Kinchington, H.O. Kangro, and D.J. Jeffries The activity of candidate virucidal agents, low pH and genital secretions against HIV-1 in vitro Int J STD AIDS 6 1995 267 272
12. J. Ongradi, L. Ceccherini-Nelli, M. Pistello, S. Specter, and M. Bendinelli Acid sensitivity of cell-free and cell-associated HIV-1: clinical implications AIDS Res Hum Retroviruses 6 1990 1433 1436
13. R.K. Pettit, S.C. McAllister, and T.A. Hamer Response of gonococcal clinical isolates to acidic conditions J Med Microbiol 48 1999 149 156
14. A.W. Sturm, and H.C. Zanen Characteristics of Haemophilus ducreyi in culture J Clin Microbiol 19 1984 672 674
15. 2-producing lactobacilli on Neisseria gonorrhoeae growth and catalase activity J Infect Dis 170 1994 1209 1215
16. W.S. Croughan, and A.M. Behbehani Comparative study of inactivation of herpes simplex virus types 1 and 2 by commonly used antiseptic agents J Clin Microbiol 26 1988 213 215
17. L. Shedlovsky, D. Belcher, and I. Levenstein Titrations of human seminal fluid with acids and alkalis and their effect on the survival of sperm motility Am J Physiol 136 1942 105 120
18. T. Mann The biochemistry of semen 1964 Wiley New York
19. S. Garg, R.A. Anderson, and C.J. Chany II et al. Properties of a new acid-buffering bioadhesive vaginal formulation (ACIDFORM) Contraception 64 2001 67 75
20. S.S. Olmsted, N.H. Dubin, R.A. Cone, and T.R. Moench The rate at which human sperm are immobilized and killed by mild acidity Fertil Steril 73 2000 687 693
21. W.H. Masters, and V.E. Johnson The physiology of the vaginal reproductive function West J Surg Obstet Gynecol 69 1961 105 120
22. E. Amaral, A. Faundes, L. Zaneveld, D. Waller, and S. Garg Study of the vaginal tolerance to Acidform, an acid-buffering, bioadhesive gel Contraception 60 1999 361 366
23. E. Amaral, A. Perdigao, and M.H. Souza et al. Postcoital testing after the use of a bio-adhesive acid buffering gel (ACIDFORM) and a 2% nonoxynol-9 product Contraception 70 2004 492 497
24. E. Hardy, K.S. de Padua, A.L. Jimenez, and L.J. Zaneveld Women's preferences for vaginal antimicrobial contraceptives II. Preferred characteristics according to women's age and socioeconomic status. Contraception 58 1998 239 244
25. J.L. Martino, and S.H. Vermund Vaginal douching: evidence for risks or benefits to women's health Epidemiol Rev 24 2002 109 124
26. L. Myer, L. Kuhn, Z.A. Stein, T.C. Wright Jr., and L. Denny Intravaginal practices, bacterial vaginosis, and women's susceptibility to HIV infection: epidemiological evidence and biological mechanisms Lancet Infect Dis 5 2005 786 794
27. T. Simpson, J. Merchant, D.M. Grimley, and M.K. Oh Vaginal douching among adolescent and young women: more challenges than progress J Pediatr Adolesc Gynecol 17 2004 249 255
28. R.B. Ness, S.L. Hillier, and H.E. Richter et al. Douching in relation to bacterial vaginosis, lactobacilli, and facultative bacteria in the vagina Obstet Gynecol 100 2002 765
29. A.M. Hilber, M.F. Chersich, J.H. van de Wijgert, H. Rees, and M. Temmerman Vaginal practices, microbicides and HIV: what do we need to know? Sex Transm Dis 83 2007 505 508
30. B.A. Koblin, K. Mayer, and A. Mwatha et al. Douching practices among women at high risk of HIV infection in the United States: implications for microbicide testing and use Sex Transm Dis 29 2002 406 410
31. F.M. Behets, A.N. Turner, and K. Van Damme et al. Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar Sex Transm Dis 35 2008 818 826
32. A. Penman-Aguilar, J. Legardy-Williams, and A.N. Turner et al. Effect of treatment assignment on intravaginal cleansing in a randomized study of the diaphragm with candidate microbicide J Womens Health 20 2011 187 195
33. E. Amaral, A. Perdigao, and M.H. Souza et al. Vaginal safety after use of a bioadhesive, acid-buffering, microbicidal contraceptive gel (ACIDFORM) and a 2% nonoxynol-9 product Contraception 73 2006 542 547
34. M.J. Keller, C.A. Carpenter, and Y. Lo et al. Phase I randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive PloS One 7 2012 e46901
35. D.L. Williams, D.R. Newman, and S.A. Ballagh et al. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm Sex Transm Dis 34 2007 977 984
36. D.J. Anderson, D.L. Williams, and S.A. Ballagh et al. Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid Am J Reprod Immunol 61 2009 121 129
37. C.E. von Mollendorf, L. Van Damme, and J.A. Moyes et al. Results: of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y Jelly Contraception 81 2010 232 239
38. R.N. Fichorova, L.D. Tucker, and D.J. Anderson The molecular basis of nonoxynol-9-induced vaginal inflammation and its possible relevance to human immunodeficiency virus type 1 transmission J Infect Dis 184 2001 418 428
39. S. Cauci, S. Guaschino, and D. De Aloysio et al. Interrelationships of interleukin-8 with interleukin-1beta and neutrophils in vaginal fluid of healthy and bacterial vaginosis positive women Mol Hum Reprod 9 2003 53 58
40. S.R. Hedges, F. Barrientes, R.A. Desmond, and J.R. Schwebke Local and systemic cytokine levels in relation to changes in vaginal flora J Infect Dis 193 2006 556 562
41. K. Doh, P.T. Barton, and I. Korneeva et al. Differential vaginal expression of interleukin-1 system cytokines in the presence of Mycoplasma hominis and Ureaplasma urealyticum in pregnant women Infect Dis Obstet Gynecol 12 2004 79 85
42. L. Belec, R. Gherardi, and C. Payan et al. Proinflammatory cytokine expression in cervicovaginal secretions of normal and HIV-infected women Cytokine 7 1995 568 574
43. A. Moriyama, K. Shimoya, and I. Ogata et al. Secretory leukocyte protease inhibitor (SLPI) concentrations in cervical mucus of women with normal menstrual cycle Mol Hum Reprod 5 1999 656 661
44. T.M. Hooton, D. Scholes, and J.P. Hughes et al. A prospective study of risk factors for symptomatic urinary tract infection in young women N Engl J Med 335 1996 468 474
45. Evofem. Study of the contraceptive efficacy and safety of amphora gel compared to conceptrol vaginal gel. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2011 - [cited 2013 July 12]. Available from: http://clinicaltrials.gov/ct2/show/NCT01306331 NLM Identifier: NCT01306331.
46. J.L. Schwartz, A. Poindexter, S.W. Schmitz, C. Mauck, and M.M. Callahan Male tolerance of ACIDFORM gel Contraception 71 2005 443 446
47. D. Herbenick, M. Reece, D. Hensel, S. Sanders, K. Jozkowski, and J.D. Fortenberry Association of lubricant use with women's sexual pleasure, sexual satisfaction, and genital symptoms: a prospective daily diary study J Sex Med 8 2011 202 212
48. M. Gabbay, and A. Gibbs Does additional lubrication reduce condom failure? Contraception 53 1996 155 158
49. M. Steiner, C. Piedrahita, L. Glover, C. Joanis, A. Spruyt, and R. Foldesy The impact of lubricants on latex condoms during vaginal intercourse Int J STD AIDS 5 1994 29 36
50. M. Aldunate, D. Tyssen, and A. Johnson et al. Vaginal concentrations of lactic acid potently inactivate HIV J Antimicrob Chemother 68 2013 2015 2025
51. S.E. Spencer, I.E. Valentin-Bon, K. Whaley, and A.E. Jerse Inhibition of Neisseria gonorrhoeae genital tract infection by leading-candidate topical microbicides in a mouse model J Infect Dis 189 2004 410 419
52. A.C. Tuyama, N. Cheshenko, and M.J. Carlucci et al. ACIDFORM inactivates herpes simplex virus and prevents genital herpes in a mouse model: optimal candidate for microbicide combinations J Infect Dis 194 2006 795 803
53. D.E. O'Hanlon, T.R. Moench, and R.A. Cone In vaginal fluid, bacteria associated with bacterial vaginosis can be suppressed with lactic acid but not hydrogen peroxide BMC Infect Dis 11 2011 200
54. J.A. Simoes, L.G. Bahamondes, and R.P. Camargo et al. A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis Br J Clin Pharmacol 61 2006 211 217
55. J. Ravel, P. Gajer, and L. Fu et al. Twice-daily application of HIV microbicides alter the vaginal microbiota MBio 2012 3
56. J.C. Peek, and C.D. Matthews The pH of cervical mucus, quality of semen, and outcome of the post-coital test Clin Reprod Fertil 4 1986 217 225
57. A. Makler, R. David, Z. Blumenfeld, and O.S. Better Factors affecting sperm motility. VII. Sperm viability as affected by change of pH and osmolarity of semen and urine specimens Fertil Steril 36 1981 507 511
58. World Health Organization WHO laboratory manual for the examination and processing of human semen 2010 World Health Organization Geneva
59. J.W. van der Steeg, P. Steures, and M.J. Eijkemans et al. Should the post-coital test (PCT) be part of the routine fertility work-up? Hum Reprod 19 2004 1373 1379
60. S.G. Oei, F.M. Helmerhorst, and M.J. Keirse When is the post-coital test normal? A critical appraisal Hum Reprod 10 1995 1711 1714
61. Q. Abdool Karim, S.S. Abdool Karim, and J.A. Frohlich et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women Science 329 2010 1168 1174