Background Nonoxynol 9 is a proved spermicide, but whether itis also a microbicide is uncertain. A truly effective vaginalmicrobicide would reduce the susceptibility of women to sexuallytransmitted diseases, including infection with the human immunodeficiencyvirus (HIV).
Methods We enrolled 1292 HIV-negative female sex workers inCameroon in a double-blind, placebo-controlled study in whichthe participants were randomly assigned to use either a filmcontaining 70 mg of nonoxynol 9 or a placebo film, insertedinto the vagina before intercourse. All of the women were providedwith latex condoms and were instructed to have their male sexualpartners use them. At monthly follow-up visits, we examinedthe women with a colposcope for genital lesions, tested endocervicalspecimens for gonorrhea and chlamydia infection with DNA probes,tested for HIV infection, and treated the women for curablesexually transmitted diseases.
Results The rates of HIV infection (cases per 100 woman-years)were 6.7 in the nonoxynol 9 group and 6.6 in the placebo group(rate ratio, 1.0; 95 percent confidence interval, 0.7 to 1.5).The rates of genital lesions were 42.2 cases per 100 woman-yearsin the nonoxynol 9 group and 33.5 in the placebo group (rateratio, 1.3; 95 percent confidence interval, 1.0 to 1.6). Therates of gonorrhea were 33.3 and 31.1 cases per 100 woman-yearsin the nonoxynol 9 and placebo groups, respectively (rate ratio,1.1; 95 percent confidence interval, 0.8 to 1.4). The correspondingrates of chlamydia infection in the nonoxynol 9 group and theplacebo group were 20.6 and 22.2 cases per 100 woman-years (rateratio, 0.9; 95 percent confidence interval, 0.7 to 1.3). Thewomen reported that condoms were used during 90 percent of sexualacts.
Conclusions The use of a nonoxynol 9 vaginal film did not reducethe rate of new HIV, gonorrhea, or chlamydia infection in thisgroup of sex workers who used condoms and received treatmentfor sexually transmitted diseases.
Source Information
From the Epidemiology Unit (R.E.R., K.A.R., S.S.W.) and the Biostatistics Division (E.L.W.), Family Health International, Durham, N.C.; and the Ministry of Public Health, Yaoundé, Cameroon (L.Z., U.T.).
Address reprint requests to Mr. Roddy at Family Health International, P.O. Box 13950, Durham, NC 27709.
Ambrose, Z., Compton, L., Piatak, M. Jr., Lu, D., Alvord, W. G., Lubomirski, M. S., Hildreth, J. E. K., Lifson, J. D., Miller, C. J., KewalRamani, V. N.
(2008). Incomplete Protection against Simian Immunodeficiency Virus Vaginal Transmission in Rhesus Macaques by a Topical Antiviral Agent Revealed by Repeat Challenges. J. Virol.
82: 6591-6599
[Abstract][Full Text]
D'Cruz, O. J., Uckun, F. M.
(2006). Dawn of non-nucleoside inhibitor-based anti-HIV microbicides. J Antimicrob Chemother
57: 411-423
[Abstract][Full Text]
Doncel, G. F.
(2006). Exploiting common targets in human fertilization and HIV infection: development of novel contraceptive microbicides. Hum Reprod Update
12: 103-117
[Abstract][Full Text]
Beer, B. E., Doncel, G. F., Krebs, F. C., Shattock, R. J., Fletcher, P. S., Buckheit, R. W. Jr., Watson, K., Dezzutti, C. S., Cummins, J. E., Bromley, E., Richardson-Harman, N., Pallansch, L. A., Lackman-Smith, C., Osterling, C., Mankowski, M., Miller, S. R., Catalone, B. J., Welsh, P. A., Howett, M. K., Wigdahl, B., Turpin, J. A., Reichelderfer, P.
(2006). In Vitro Preclinical Testing of Nonoxynol-9 as Potential Anti-Human Immunodeficiency Virus Microbicide: a Retrospective Analysis of Results from Five Laboratories. Antimicrob. Agents Chemother.
50: 713-723
[Abstract][Full Text]
Shah, V., Doncel, G. F., Seyoum, T., Eaton, K. M., Zalenskaya, I., Hagver, R., Azim, A., Gross, R.
(2005). Sophorolipids, Microbial Glycolipids with Anti-Human Immunodeficiency Virus and Sperm-Immobilizing Activities. Antimicrob. Agents Chemother.
49: 4093-4100
[Abstract][Full Text]
Scordi-Bello, I. A., Mosoian, A., He, C., Chen, Y., Cheng, Y., Jarvis, G. A., Keller, M. J., Hogarty, K., Waller, D. P., Profy, A. T., Herold, B. C., Klotman, M. E.
(2005). Candidate Sulfonated and Sulfated Topical Microbicides: Comparison of Anti-Human Immunodeficiency Virus Activities and Mechanisms of Action. Antimicrob. Agents Chemother.
49: 3607-3615
[Abstract][Full Text]
D'cruz, O. J., Erbeck, D., Uckun, F. M.
(2005). A Study of the Potential of the Pig as a Model for the Vaginal Irritancy of Benzalkonium Chloride in Comparison to the Nonirritant Microbicide PHI-443 and the Spermicide Vanadocene Dithiocarbamate. Toxicol Pathol
33: 465-476
[Abstract][Full Text]
Catalone, B. J., Kish-Catalone, T. M., Neely, E. B., Budgeon, L. R., Ferguson, M. L., Stiller, C., Miller, S. R., Malamud, D., Krebs, F. C., Howett, M. K., Wigdahl, B.
(2005). Comparative Safety Evaluation of the Candidate Vaginal Microbicide C31G. Antimicrob. Agents Chemother.
49: 1509-1520
[Abstract][Full Text]
Fichorova, R.N., Bajpai, M., Chandra, N., Hsiu, J.G., Spangler, M., Ratnam, V., Doncel, G.F.
(2004). Interleukin (IL)-1, IL-6, and IL-8 Predict Mucosal Toxicity of Vaginal Microbicidal Contraceptives. Biol. Reprod.
71: 761-769
[Abstract][Full Text]
D'Cruz, O. J., Uckun, F. M.
(2002). Pre-clinical safety evaluation of novel nucleoside analogue-based dual-function microbicides (WHI-05 and WHI-07). J Antimicrob Chemother
50: 793-803
[Abstract][Full Text]
Piret, J., Roy, S., Gagnon, M., Landry, S., Desormeaux, A., Omar, R. F., Bergeron, M. G.
(2002). Comparative Study of Mechanisms of Herpes Simplex Virus Inactivation by Sodium Lauryl Sulfate and n-Lauroylsarcosine. Antimicrob. Agents Chemother.
46: 2933-2942
[Abstract][Full Text]
Krebs, F. C., Miller, S. R., Catalone, B. J., Fichorova, R., Anderson, D., Malamud, D., Howett, M. K., Wigdahl, B.
(2002). Comparative In Vitro Sensitivities of Human Immune Cell Lines, Vaginal and Cervical Epithelial Cell Lines, and Primary Cells to Candidate Microbicides Nonoxynol 9, C31G, and Sodium Dodecyl Sulfate. Antimicrob. Agents Chemother.
46: 2292-2298
[Abstract][Full Text]
Anderson, R. A., Feathergill, K. A., Diao, X.-H., Cooper, M. D., Kirkpatrick, R., Herold, B. C., Doncel, G. F., Chany, C. J., Waller, D. P., Rencher, W. F., Zaneveld, L. J.D.
(2002). Preclinical Evaluation of Sodium Cellulose Sulfate (Ushercell) as a Contraceptive Antimicrobial Agent. J Androl
23: 426-438
[Abstract][Full Text]
Zaneveld, L. J.D., Waller, D. P., Anderson, R. A., Chany II, C., Rencher, W. F., Feathergill, K., Diao, X.-H., Doncel, G. F., Herold, B., Cooper, M.
(2002). Efficacy and Safety of a New Vaginal Contraceptive Antimicrobial Formulation Containing High Molecular Weight Poly(Sodium 4-Styrenesulfonate). Biol. Reprod.
66: 886-894
[Abstract][Full Text]
Roddy, R. E., Zekeng, L., Ryan, K. A., Tamoufe, U., Tweedy, K. G.
(2002). Effect of Nonoxynol-9 Gel on Urogenital Gonorrhea and Chlamydial Infection: A Randomized Controlled Trial. JAMA
287: 1117-1122
[Abstract][Full Text]
Richardson, B. A.
(2002). Nonoxynol-9 as a Vaginal Microbicide for Prevention of Sexually Transmitted Infections: It's Time to Move On. JAMA
287: 1171-1172
[Full Text]
Holtz, A. S., Cates, Jr, W., Rosenberg, Z., Raymond, E., Fontanarosa, P. B., Flanagin, A.
(2001). When Should the Public Be Informed of the Results of Medical Research?. JAMA
286: 2944-2945
[Full Text]
Bestman-Smith, J., Piret, J., Desormeaux, A., Tremblay, M. J., Omar, R. F., Bergeron, M. G.
(2001). Sodium Lauryl Sulfate Abrogates Human Immunodeficiency Virus Infectivity by Affecting Viral Attachment. Antimicrob. Agents Chemother.
45: 2229-2237
[Abstract][Full Text]
Roy, S., Gourde, P., Piret, J., Désormeaux, A., Lamontagne, J., Haineault, C., Omar, R. F., Bergeron, M. G.
(2001). Thermoreversible Gel Formulations Containing Sodium Lauryl Sulfate or n-Lauroylsarcosine as Potential Topical Microbicides against Sexually Transmitted Diseases. Antimicrob. Agents Chemother.
45: 1671-1681
[Abstract][Full Text]
Barnhart, K.T., Stolpen, A., Pretorius, E.S., Malamud, D.
(2001). Distribution of a spermicide containing Nonoxynol-9 in the vaginal canal and the upper female reproductive tract: Case report. Hum Reprod
16: 1151-1154
[Abstract][Full Text]
McCormack, S., Hayes, R., Lacey, C. J N, Johnson, A. M
(2001). Science, medicine, and the future: Microbicides in HIV prevention. BMJ
322: 410-413
[Full Text]
Kawamura, T., Cohen, S. S., Borris, D. L., Aquilino, E. A., Glushakova, S., Margolis, L. B., Orenstein, J. M., Offord, R. E., Neurath, A. R., Blauvelt, A.
(2000). Candidate Microbicides Block HIV-1 Infection of Human Immature Langerhans Cells within Epithelial Tissue Explants. J. Exp. Med.
192: 1491-1500
[Abstract][Full Text]
Manson, K. H., Wyand, M. S., Miller, C., Neurath, A. R.
(2000). Effect of a Cellulose Acetate Phthalate Topical Cream on Vaginal Transmission of Simian Immunodeficiency Virus in Rhesus Monkeys. Antimicrob. Agents Chemother.
44: 3199-3202
[Abstract][Full Text]
Krebs, F. C., Miller, S. R., Catalone, B. J., Welsh, P. A., Malamud, D., Howett, M. K., Wigdahl, B.
(2000). Sodium Dodecyl Sulfate and C31G as Microbicidal Alternatives to Nonoxynol 9: Comparative Sensitivity of Primary Human Vaginal Keratinocytes. Antimicrob. Agents Chemother.
44: 1954-1960
[Abstract][Full Text]
D'Cruz, O. J., Venkatachalam, T. K., Uckun, F. M.
(2000). Novel Thiourea Compounds as Dual-Function Microbicides. Biol. Reprod.
63: 196-205
[Abstract][Full Text]
Donovan, B.
(2000). The repertoire of human efforts to avoid sexually transmissible diseases: past and present. Part 2: Strategies used during or after sex. Sex. Transm. Infect.
76: 88-93
[Abstract][Full Text]
Van Damme, L., Wright, A., Depraetere, K., Rosenstein, I., Vandersmissen, V., Poulter, L., McKinlay, M., Van Dyck, E., Weber, J., Profy, A., Laga, M., Kitchen, V.
(2000). A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex. Transm. Infect.
76: 126-130
[Abstract][Full Text]
Piret, J., Lamontagne, J., Bestman-Smith, J., Roy, S., Gourde, P., Désormeaux, A., Omar, R. F., Juhász, J., Bergeron, M. G.
(2000). In Vitro and In Vivo Evaluations of Sodium Lauryl Sulfate and Dextran Sulfate as Microbicides against Herpes Simplex and Human Immunodeficiency Viruses. J. Clin. Microbiol.
38: 110-119
[Abstract][Full Text]
D'Cruz, O. J., Venkatachalam, T. K., Uckun, F. M.
(2000). Structural Requirements for Potent Human Spermicidal Activity of Dual-Function Aryl Phosphate Derivative of Bromo-Methoxy Zidovudine (Compound WHI-07). Biol. Reprod.
62: 37-44
[Abstract][Full Text]
D'Cruz, O. J., Uckun, F. M.
(1999). Novel Derivatives of Phenethyl-5-Bromopyridylthiourea and Dihydroalkoxybenzyloxopyrimidine Are Dual-Function Spermicides with Potent Anti-Human Immunodeficiency Virus Activity. Biol. Reprod.
60: 1419-1428
[Abstract][Full Text]
D'Cruz, O. J., Shih, M.-J., Yiv, S. H., Chen, C.-L., Uckun, F. M.
(1999). Synthesis, characterization and preclinical formulation of a dual-action phenyl phosphate derivative of bromo-methoxy zidovudine (compound WHI-07) with potent anti-HIV and spermicidal activities. Mol Hum Reprod
5: 421-432
[Abstract][Full Text]
(1998). Nonoxynol 9 Fails to Protect Against Sexually Transmitted Diseases. JWatch Infect. Diseases
1998: 13-13
[Full Text]
(1998). Nonoxynol 9 Film Does Not Reduce STD Transmission. JWatch Women's Health
1998: 3-3
[Full Text]
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