Expanded safety and acceptability of the candidate vaginal microbicide Carraguard® in South Africa

Contraception

Volumn 82, Issue 6, 2010, Pages 563-571

  Altini, Lydia ^a   Blanchard, Kelly ^b   Coetzee, Nicol ^a   De Kock, Alana ^a   Elias, Christopher ^b   Ellertson, Charlotte ^b   Friedland, Barbara ^b   Hoosen, Anwar ^c   Jones, Heidi E ^b   Kilmarx, Peter H ^d   Marumo, Mabitso ^c   McGrory, Elizabeth ^b   Monedi, Constance ^c   Ndlovu, Gugulethu ^b   Nkompala, Bels ^a   Pistorius, Annalie ^c   Ramjee, Gita ^e   Sebola, Mohlatlego ^b   Sorhaindo, Annik ^b   Norris Turner, Abigail ^b   Tweedy, Kathryn ^f   Van De Wijgert, Janneke ^b   Williams, Manuela M ^c   Winikoff, Beverly ^b   more..

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b POPULATION COUNCIL   (United States)

^c UNIVERSITY OF LIMPOPO   (South Africa)

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

^e SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

^f FAMILY HEALTH INTERNATIONAL   (United States)

Author keywords

Acceptability; Carraguard; HIV prevention; Microbicide; Safety; South Africa

Indexed keywords

CARRAGEENAN; MICROBICIDE; PC 515; PLACEBO; UNCLASSIFIED DRUG;

ADULT; APPLICATION SITE REACTION; ARTICLE; BILIARY TRACT DISEASE; CANDIDA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; FEMALE; FOLLOW UP; GASTROINTESTINAL DISEASE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; LIVER DISEASE; MAJOR CLINICAL STUDY; MEDICAL APPARATUS, EQUIPMENT AND SUPPLIES; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; REPRODUCTIVE TOXICITY; SEXUALLY TRANSMITTED DISEASE; SOUTH AFRICA; TREATMENT DURATION; TRIPLE BLIND PROCEDURE; VAGINA APPLICATOR; VAGINA CANDIDIASIS; VAGINA EPITHELIUM; VAGINA EPITHELIUM DISRUPTION; VAGINA PAIN; VAGINAL BURNING SENSATION; VAGINAL PRURITUS; VAGINITIS;

ADMINISTRATION, INTRAVAGINAL; ADOLESCENT; ADULT; ANTI-INFECTIVE AGENTS; CARRAGEENAN; COITUS; FEMALE; HUMANS; MIDDLE AGED; SEXUALLY TRANSMITTED DISEASES; SOUTH AFRICA; VAGINAL CREAMS, FOAMS, AND JELLIES; YOUNG ADULT;

EID: 78249240861     PISSN: 00107824     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.contraception.2010.04.019     Document Type: Article

References (31)

1. UNAIDS/WHO AIDS epidemic update 2007 UNAIDS/World Health Organization Geneva Available at http://data.unaids.org/pub/EPISlides/2007/2007-epiupdate-en. pdf Accessed Sept 8, 2008
2. Heise L.L., and Elias C. Transforming AIDS prevention to meet women's needs: a focus on developing countries Soc Sci Med 40 1995 931 943
3. Nahmias A.J., Kibrick S., and Bernfeld P. Effect of synthetic and biological polyanions on herpes simplex virus Proc Soc Exp Biol Med 115 1964 993 996
4. Zacharapoulos V.R., and Phillips D.M. Vaginal formulations of carrageenan protect mice from herpes simplex virus infection Clin Diagn Lab Immunol 4 1997 465 468
5. Pearce-Pratt R., and Phillips D.M. Sulfated polysaccharides inhibit lymphocyte-to-epithelial transmission of human immunodeficiency virus-1 Biol Reprod 54 1996 173 182
6. 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
7. Elias C.J., Coggins C., and Alvarez F. Colposcopic evaluation of a vaginal gel formulation of iota-carrageenan Contraception 56 1997 387 389
8. Coggins C., Blanchard K., and Alvarez F. Preliminary safety and acceptability of a carrageenan gel for possible use as a vaginal microbicide Sex Transm Infect 76 2000 480 483
9. Kilmarx P.H., van de Wijgert J.H., and Chaikummao S. 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
10. Skoler-Karpoff S., Ramjee G., and Ahmed K. Efficacy of Carraguard for prevention of HIV infection in women in South Africa: a randomised, double-blind, placebo-controlled trial Lancet 372 2008 1977 1987
11. Fernandez-Romero J.A., Thorn M., and Turville S.G. Carrageenan/MIV-150 (PC-815), a combination microbicide Sex Transm Dis 34 2007 9 14
12. Poynten I.M., Millwood I.Y., and Falster M.O. The safety of candidate vaginal microbicides since nonoxynol-9: a systematic review of published studies AIDS 23 2009 1245 1254
13. International Working Group on Vaginal Microbicides Recommendations for the development of vaginal microbicides AIDS 10 1996 UNAIDS1 6
14. Mauck C., Rosenberg Z., Van Damme L. for the International Working Group on Microbicides Recommendations for the clinical development of topical microbicides: an update AIDS 15 2001 857 868
15. Heise L., McGrory C.E., and Wood S.Y. Practical and ethical dilemmas in the clinical testing of microbicides: a report on a symposium 1998 International Women's Health Coalition New York
16. Maguire R.A., Zacharopoulos V.R., and Phillips D.M. Carrageenan-based nonoxynol-9 spermicides for prevention of sexually transmitted infections Sex Transm Dis 25 1998 494 500
17. Bell R.J., Permezel M., MacLennan A., Hughes C., Healy D., and Brennecke S. A randomized, double-blind, placebo-controlled trial of the safety of vaginal recombinant human relaxin for cervical ripening Obstet Gynecol 82 1993 328 333
18. Elliott J.P., Clewell W.H., and Radin T.G. Intracervical prostaglandin E2 gel. Safety for outpatient cervical ripening before induction of labor J Reprod Med 37 1992 713 716
19. Sacks S.L., Varner T.L., and Davies K.S. Randomized, double-blind, placebo-controlled, patient-initiated study of topical high- and low-dose interferon-alpha with nonoxynol-9 in the treatment of recurrent genital herpes J Infect Dis 161 1990 692 698
20. 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
21. Rothman K.J., and Greenland S. Modern epidemiology 2nd ed 1998 Lippincott-Raven Publishers Philadelphia, PA
22. WHO Collaborating Centre for International Drug Monitoring International monitoring of adverse reactions to drugs: adverse reaction terminology, 31 December 1992 (WHO adverse reaction dictionary) 1992 WHO Collaborating Centre for International Drug Monitoring Uppsala, Sweden Available at http://www.who-umc.org (products and services link). Accessed May 13, 2003
23. Fraser I.S., Lähteenmäki P., and Elomaa K. Variations in vaginal epithelial surface appearance determined by colposcopic inspection in healthy, sexually active women Hum Reprod 14 1999 1974 1978
24. Kilmarx P.H., Blanchard K., and Chaikummao S. A randomized, placebo-controlled trial to assess the safety and acceptability of use of Carraguard vaginal gel by heterosexual couples in Thailand Sex Transm Dis 35 2008 226 232
25. Myer L., Denny L., Telerant R., Souza M., Wright T.C. Jr, and Kuhn L. Bacterial vaginosis and susceptibility to HIV infection in South African women: a nested case-control study J Infect Dis 192 2005 1372 1380
26. Chersich M.F., and Rees H.V. Vulnerability of women in southern Africa to infection with HIV: biological determinants and priority health sector interventions AIDS 22 Suppl 4 2008 S27 S40
27. van de Wijgert J.H., Morrison C.S., and Cornelisse P.G. Bacterial vaginosis and vaginal yeast, but not vaginal cleansing, increase HIV-1 acquisition in African women J Acquir Immune Defic Syndr 48 2008 203 210
28. Myer L., Denny L., de Souza M., Wright T.C. Jr, and Kuhn L. Distinguishing the temporal association between women's intravaginal practices and risk of human immunodeficiency virus infection: a prospective study of South African women Am J Epidemiol 163 2006 552 560
29. Beksinska M.E., Rees H.V., Kleinschmidt I., and McIntyre J. The practice and prevalence of dry sex among men and women in South Africa: a risk factor for sexually transmitted infections? Sex Transm Infect 75 1999 178 180
30. Pistorius A.G., van de Wijgert J.H.H.M., and Sebola M. Microbicide trials for preventing HIV/AIDS in South Africa: Phase II trial participants' experiences and psychological needs SAHARA J 1 2004 78 86
31. Turner A.N., de Kock A.E., and Meehan-Ritter A. Many vaginal microbicide trial participants acknowledged they had misreported sensitive sexual behavior in face-to-face interviews J Clin Epidemiol 62 2009 759 765