Randomized trial of periodic presumptive treatment with high-dose intravaginal metronidazole and miconazole to prevent vaginal infections in HIV-negative women

Journal of Infectious Diseases

Volumn 211, Issue 12, 2015, Pages 1875-1882

  McClelland, R Scott ^a,b,d   Balkus, Jennifer E ^b,c   Lee, Jeannette ^f   Anzala, Omu ^e   Kimani, Joshua ^d   Schwebke, Jane ^g   Bragg, Vivian ^h   Lensing, Shelly ^f   Kavak, Lale ⁱ  

^a Department of Medicine ^*  (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c Fred Hutchinson Cancer Research Center   (United States)

^d Institute of Tropical and Infectious Diseases   (United States)

^e UNIVERSITY OF NAIROBI   (Kenya)

^f UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^g University of Alabama at Birmingham   (United States)

^h FHI 360   (United States)

ⁱ Embil Pharmaceutical Company Limited   (Turkey)

Author keywords

bacterial vaginosis; metronidazole; miconazole; periodic presumptive treatment; Trichomonas vaginalis; vulvovaginal candidiasis

Indexed keywords

ANTIFUNGAL AGENT; FLUCONAZOLE; METRONIDAZOLE; METRONIDAZOLE PLUS MICONAZOLE; PLACEBO; UNCLASSIFIED DRUG; ANTIINFECTIVE AGENT; MICONAZOLE;

ADULT; ARTICLE; BACKACHE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; EVENING DOSAGE; FEMALE; FOLLOW UP; FUNGAL CELL CULTURE; GRAM STAINING; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; PATIENT COMPLIANCE; PELVIC EXAMINATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SINGLE DRUG DOSE; TRICHOMONAS VAGINALIS; TRICHOMONIASIS; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; UTERINE CERVIX CYTOLOGY; VAGINA CANDIDIASIS; VAGINA DISCHARGE; VAGINA SMEAR; VAGINAL PRURITUS; VAGINITIS; VULVA PRURITUS; VULVOVAGINITIS; YOUNG ADULT; ADOLESCENT; CANDIDIASIS, VULVOVAGINAL; CHEMOPROPHYLAXIS; MIDDLE AGED; PRE-EXPOSURE PROPHYLAXIS; PROCEDURES; TREATMENT OUTCOME; TRICHOMONAS VAGINITIS; VAGINOSIS, BACTERIAL;

ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; CANDIDIASIS, VULVOVAGINAL; CHEMOPREVENTION; FEMALE; HUMANS; METRONIDAZOLE; MICONAZOLE; MIDDLE AGED; PLACEBOS; PRE-EXPOSURE PROPHYLAXIS; TREATMENT OUTCOME; TRICHOMONAS VAGINITIS; VAGINOSIS, BACTERIAL; YOUNG ADULT;

EID: 84930340300     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/jiu818     Document Type: Article

References (33)

1. Martin HL Jr, Nyange PM, Richarson BA, et al. Hormonal contraception, sexually transmitted diseases, and risk of heterosexual transmission of human immunodeficiency virus type 1. J Infect Dis 1998; 178: 1053-59.
2. Taha TE, Hoover DR, Dallabetta GA, et al. Bacterial vaginosis and disturbances of vaginal flora: association with increased acquisition of HIV. AIDS 1998; 12:1699-706.
3. Myer L, Denny L, Telerant R, Souza M,Wright TC Jr, Kuhn L. Bacterial vaginosis and susceptibility to HIV infection in South African women: a nested case-control study. J Infect Dis 2005; 192:1372-80.
4. van de Wijgert JH, Morrison CS, Cornelisse PG, et al. Bacterial vaginosis and vaginal yeast, but not vaginal cleansing, increase HIV-1 acquisition in African women. J Acquir Immune Defic Syndr 2008; 48: 203-10.
5. Kilmarx PH, Limpakarnjanarat K, Mastro TD, et al. HIV-1 seroconverson in a prospective study of female sex workers in northern Thailand: continued high incidence among brothel-based women. AIDS 1998; 12:1889-98.
6. Kapiga SH, Lyamuya EF, Lwihula GK, Hunter DJ. The incidence of HIV infection among women using family planning methods in Dar es Salaam, Tanzania. AIDS 1998; 12:75-84.
7. Laga M, Alary M, Nzila N, et al. Condom promotion, sexually transmitted diseases treatment, and declining incidence of HIV-1 infection in female Zairian sex workers. Lancet 1994; 344:246-8.
8. McClelland RS, Sangare L, Hassan WM, et al. Infection with Trichomonas vaginalis increases the risk of HIV-1 acquisition. J Infect Dis 2007; 195:698-702.
9. Van Der Pol B, Kwok C, Pierre-Louis B, et al. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. J Infect Dis 2008; 197:548-54.
10. Cherpes TL, Meyn LA, Krohn MA, Lurie JG, Hillier SL. Association between acquisition of herpes simplex virus type 2 in women and bacterial vaginosis. Clin Infect Dis 2003; 37:319-25.
11. Gallo MF,Warner L, Macaluso M, et al. Risk factors for incident herpes simplex type 2 virus infection among women attending a sexually transmitted disease clinic. Sex Transm Dis 2008; 35:679-85.
12. Gottlieb SL, Douglas JM Jr, Foster M, et al. Incidence of herpes simplex virus type 2 infection in 5 sexually transmitted disease (STD) clinics and the effect of HIV/STD risk-reduction counseling. J Infect Dis 2004; 190:1059-67.
13. Mao C, Hughes JP, Kiviat N, et al. Clinical findings among young women with genital human papillomavirus infection. Am J Obstet Gynecol 2003; 188:677-84.
14. Gallo MF, Macaluso M, Warner L, et al. Bacterial vaginosis, gonorrhea, and chlamydial infection amongwomen attending a sexually transmitted disease clinic: a longitudinal analysis of possible causal links. Ann Epidemiol 2012; 22:213-20.
15. Brotman RM, Klebanoff MA, Nansel TR, et al. Bacterial vaginosis assessed by gram stain and diminished colonization resistance to incident gonococcal, chlamydial, and trichomonal genital infection. J Infect Dis 2010; 202:1907-15.
16. Rathod SD, Krupp K, Klausner JD, Arun A, Reingold AL, Madhivanan P. Bacterial vaginosis and risk for Trichomonas vaginalis infection: a longitudinal analysis. Sex Transm Dis 2011; 38:882-6.
17. Balkus JE, Richardson BA, Rabe LK, et al. Bacterial vaginosis and the risk of Trichomonas vaginalis acquisition among HIV-1-negative women. Sex Transm Dis 2014; 41:123-8.
18. Schwebke JR, Desmond R. A randomized trial of metronidazole in asymptomatic bacterial vaginosis to prevent the acquisition of sexually transmitted diseases. Am J Obstet Gynecol 2007; 196:517 e1-6.
19. Sobel JD, Ferris D, Schwebke J, et al. Suppressive antibacterial therapy with 0.75% metronidazole vaginal gel to prevent recurrent bacterial vaginosis. Am J Obstet Gynecol 2006; 194:1283-9.
20. Taha TE, Kumwenda NI, Kafulafula G, et al. Intermittent intravaginal antibiotic treatment of bacterial vaginosis in HIV-uninfected and-infected women: a randomized clinical trial. PLOS Clin Trials 2007; 2:e10.
21. McClelland RS, Richardson BA, Hassan WM, et al. Improvement of vaginal health for Kenyan women at risk for acquisition of human immunodeficiency virus type 1: results of a randomized trial. J Infect Dis 2008; 197:1361-8.
22. Bradshaw CS, Morton AN, Hocking J, et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis 2006; 193:1478-86.
23. Sobel JD, Wiesenfeld HC, Martens M, et al. Maintenance fluconazole therapy for recurrent vulvovaginal candidiasis. N Engl J Med 2004; 351:876-83.
24. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 1991; 29:297-301.
25. Sobel JD. Vulvovaginal candidiasis. In: Holmes KK, Mardh P, Sparling PF, et al., eds. Sexually Transmitted Diseases. 4th ed. New York: McGraw-Hill, 2007:823-38.
26. Mujugira A, Morrow RA, Celum C, et al. Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries. Sex Transm Infect 2011; 87:238-41.
27. Bergman JJ, Berg AO, Schneeweiss R, Heidrich FE. Clinical comparison of microscopic and culture techniques in the diagnosis of Candida vaginitis. J Fam Pract 1984; 18:549-52.
28. Amsel R, Totten PA, Spiegel CA, Chen KCS, Eschenbach DA, Holmes KK. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am J Intern Med 1983; 74:14-22.
29. Donner A, Klar N. Design and analysis of cluster randomization trials in health research. New York, New York: Oxford University Press, 2000.
30. Ronen K, McCoy CO, Matsen FA, et al. HIV-1 superinfection occurs less frequently than initial infection in a cohort of high-risk Kenyan women. PLOS Pathog 2013; 9:e1003593.
31. Mugo NR, Hong T, Celum C, et al. Pregnancy incidence and outcomes among women receiving preexposure prophylaxis for HIV prevention: a randomized clinical trial. JAMA 2014; 312:362-71.
32. Aguin T, Akins RA, Sobel JD. High-dose vaginal maintenance metronidazole for recurrent bacterial vaginosis: a pilot study. Sex Transm Dis 2014; 41:290-1.
33. Van der Straten A, Brown ER, Marrazzo JM, et al. Divergent adherence estimates with pharmacokinetic and behavioral measures in VOICE (MTN003). In: Conference on Retroviruses and Opportunistic Infections. Boston, MA, 2014.