Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials

Contraception

Volumn 77, Issue 2, 2008, Pages 122-129

  van de Wijgert, Janneke H H M ^a,b,c   Kilmarx, Peter H ^b,c,d   Jones, Heidi E ^b,c,e   Karon, John M ^c,f   Chaikummao, Supaporn ^b,c  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b POPULATION COUNCIL   (United States)

^c Centers for Disease Control CDC Thailand Field Station   (Thailand)

^d CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^e New York Presbyterian Morgan Stanley Children's Hospital   (United States)

^f Emergint Corporation   (United States)

Author keywords

Genital irritation; HIV prevention; HIV 1; Thailand; Vaginal microbicide

Indexed keywords

CARRAGEENAN; MICROBICIDE; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; DRUG USE; FEMALE; FOLLOW UP; GEL; HERPES SIMPLEX VIRUS 2; HORMONAL CONTRACEPTION; HUMAN; INTERVIEW; MAJOR CLINICAL STUDY; MYCOSIS; PARITY; PELVIS; PHASE 2 CLINICAL TRIAL; POPULATION; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; SCORING SYSTEM; SCREENING; SECONDARY ANALYSIS; SELF REPORT; SENESCENCE; SEROLOGY; SEX; SEXUALLY TRANSMITTED DISEASE; SYMPTOM; THAILAND; UTERINE CERVIX; VAGINA ABRASION; VAGINA BLISTER; VAGINA DISEASE; VAGINA ECCHYMOSIS; VAGINA EDEMA; VAGINA ERYTHEMA; VAGINA FISSURE; VAGINA PETECHIA; VAGINAL ULCER; VAGINITIS; YEAST;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; AGE FACTORS; ANTI-INFECTIVE AGENTS; EPITHELIAL CELLS; FEMALE; HIV INFECTIONS; HUMANS; PLACEBOS; RISK FACTORS; SAFETY; SEXUAL BEHAVIOR; SEXUALLY TRANSMITTED DISEASES; THAILAND; VAGINA; VAGINAL CREAMS, FOAMS, AND JELLIES;

EID: 38549116136     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2007.10.006     Document Type: Article

References (31)

1. Alliance for Microbicide Development. Microbicide Research and Development Database (MRDD). Silverspring (Md). Alliance for Microbicide Development. At: http://www.microbicide.org.html.Accessed on August 21, 2007.
2. Miller C.J., and Shattock R.J. Target cells in vaginal HIV transmission. Microbes Infect 5 (2003) 59-67
3. World Health Organization. Manual for the standardization of colposcopy for the evaluation of vaginally administered products: an update (2000), WHO, Geneva, Switzerland
4. Bollen L., Kilmarx P.H., and Wiwatwongwana P. Photo atlas for microbicide evaluation (2002), Thailand MOPH - U.S. CDC Collaboration, Bangkok, Thailand
5. Fraser I.S., Lahteenmaki P., Elomaa K., et al. Variations in vaginal epithelial surface appearance determined by colposcopic inspection in healthy, sexually active women. Reprod 14 (1999) 1974-1978
6. van Damme L., Niruthisard S., Atisook R., et al. Safety evaluation of nonoxynol-9 gel in women at low risk of HIV infection. AIDS 12 (1998) 433-437
7. Roddy R.E., Cordero M., Cordero C., and Fortney J.A. A dosing study of nonoxynol-9 and genital irritation. Internat J STD AIDS 4 (1993) 165-170
8. Stafford M.K., Ward H., Flanagan A., et al. Safety study of nonoxynol-9 as a vaginal microbicide: evidence of adverse effects. J Acquir Immune Defic Syndr 17 (1998) 327-331
9. Van Damme L., Wright A., Depraetere K., et al. A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Inf 76 (2000) 126-130
10. van de Wijgert J., Fullem A., Kelly C., et al. Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr 26 (2001) 21-27
11. Mauck C.K., Weiner D.H., Ballagh S., et al. Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase 1 safety and colposcopy study. Contraception 64 (2001) 383-391
12. Low-Beer N., Gabe R., McCormack S., Kitchen V.S., Lacey C.J., and Nunn A.J. Dextrin sulfate as a vaginal microbicide: randomized, double-blind, placebo-controlled trial including healthy female volunteers and their male partners. J Acquir Immune Defic Syndr 31 (2002) 391-393
13. Ballagh S.A., Baker J.M., Henry D.M., and Archer D.F. Safety of single daily use for one week of C31G HEC gel in women. Contraception 66 (2002) 369-375
14. Mayer K.H., Karim S.A., Kelly C., et al., for the HIV Prevention Trials Network (HPTN) 020 protocol team. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS 17 (2003) 321-329
15. Mauck C.K., Weiner D.H., Creinin M.D., Barnhart K.T., Callahan M.M., and Bax R. A randomized phase I vaginal safety study of three concentrations of C31G vs. extra strength I.I. Gynol. Contraception 70 (2004) 233-240
16. El-Sadr W.M., Mayer K.H., Maslankowski L., et al., for the HIV Prevention Trials Network (HPTN) 049 protocol team. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS 20 (2006) 1109-1116
17. Mayer K.H., Maslankowski L., Gai F., et al., and the HPTN 050 protocol team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS 20 (2006) 543-551
18. Jespers V.A., Van Roey J.M., Beets G.I., and Buvé A.M. Dose-ranging Phase I study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers. J Acquir Immune Defic Syndr 44 (2007) 154-158
19. Kilmarx P., van de Wijgert J., Chaikummao S., et al. Safety and acceptability of the candidate microbicide Carraguard in Thai women: findings from a Phase II clinical trial. J Acquir Immune Defic Syndr 43 (2006) 327-334
20. Coggins C., Blanchard K., Alvarez F., et al. Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide. Sex Transm Infect 76 (2000) 480-483
21. Maguire R.A., Bergman N., and Phillips D.M. Comparison of microbicides for efficacy in protecting mice against vaginal challenge with herpes simplex virus type 2, cytotoxicity, antibacterial properties, and sperm immobilization. Sex Transm Dis 28 (2001) 259-265
22. Nugent R.P., Krohn M.A., and Hillier S.L. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of Gram stain interpretation. J Clin Microbiol 29 (1991) 297-301
23. Young N.L., Kilmarx P.H., Borchardt K., Chaowanachan T., Wasinrapee P., and Suksripanich O. Inhibitory effects of vaginal microbicides on COBAS Amplicor and Gen-Probe Chlamydia trachomatis and Neisseria gonorrhoeae, and InPouch Trichomonas vaginalis tests. [Abstract]. Int J STD AIDS 12 Suppl 2 (2001) 193
24. Hardin J.W., and Hilbe J.M. Generalized estimating equations (2003), Chapman and Hall/CRC, Boca Raton (Fl)
25. Therneau T.M., and Grambsch P.M. Modeling survival data: Extending the Cox model (2000), Springer, New York
26. Lincoln C. Sexual injury: is it significant? A review of the literature. Med Sci Law 41 (2001) 206-216
27. Eschenbach D.A., Patton D.L., Hooton T.M., et al. Effects of vaginal intercourse with and without a condom on vaginal flora and vaginal epithelium. J Infect Dis 183 (2001) 913-918
28. Georgijevic A.V., Sisovic J.R., Djukic S.V., and Bujko M.J. Colposcopic and cytologic findings among women with abnormal vaginal flora. J Low Genit Tract Dis 6 (2002) 155-161
29. Galhardo C.L., SoaresJr J.M., Simoes R.S., Haidar M.A., Rodrigues de Lima G., and Baracat E.C. Estrogen effects on the vaginal pH, flora and cytology in late postmenopause after a long period without hormone therapy. Clin Exp Obstet Gynecol 33 (2006) 85-89
30. Fichorova R.N. Guiding the vaginal microbicide trials with biomarkers of inflammation. J Acquir Immune Defic Syndr 37 Suppl 3 (2004) S184-S193
31. Moench T. Sensitive methods to detect epithelial disruptions: tests for microhemorrhage in cervicovaginal lavages. J Acquir Immune Defic Syndr 37 Suppl 3 (2004) S194-S200