Acceptability of Carraguard vaginal microbicide gel among HIV-infected women in Chiang rai, Thailand

PLoS ONE

Volumn 6, Issue 9, 2011, Pages

  Whitehead, Sara J ^a   McLean, Catherine ^b   Chaikummao, Supaporn ^a   Braunstein, Sarah ^c   Utaivoravit, Wat ^d   van de Wijgert, Janneke H ^c,e   Mock, Philip A ^a   Siraprapasiri, Taweesap ^a   Friedland, Barbara A ^c   Kilmarx, Peter H ^b   Markowitz, Lauri E ^b  

^a MINISTRY OF PUBLIC HEALTH   (Thailand)

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

^c POPULATION COUNCIL   (United States)

^d Chiang Rai Prachanukhro Hospital   (Thailand)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CARRAGEENAN; METHYLCELLULOSE; MICROBICIDE; PLACEBO; AGENTS USED INTRAVAGINALLY; ANTIINFECTIVE AGENT;

ADULT; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; PATIENT ATTITUDE; PATIENT COMPLIANCE; PATIENT SATISFACTION; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; THAILAND; TREATMENT RESPONSE; WOMEN'S HEALTH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DOUBLE BLIND PROCEDURE; INTRAVAGINAL DRUG ADMINISTRATION;

ADMINISTRATION, INTRAVAGINAL; ANTI-INFECTIVE AGENTS; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HUMANS; THAILAND; VAGINAL CREAMS, FOAMS, AND JELLIES;

EID: 80052527069     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0014831     Document Type: Article

References (22)

1. Harrison P, Rosenberg S, Bowcut J, (2003) Topical microbicides for disease prevention: Status and challenges. Clin Infect Dis 36: 1290-1294.
2. Alliance for Microbicide Development. Microbicide Pipeline Summary Report. Available: http://www.microbicide.org/uploads/3/1/2/1/3121935/microbicide_pipeline_update_1_oct_2009.pdf. Accessed 2011 July 23.
3. Mantell JE, Myer L, Carballo-Diéguez A, Stein Z, Ramjee G, et al. (2005) Microbicide acceptability research: Current approaches and future directions. Soc Sci Med 60: 319-330.
4. El-Sadr WM, Mayer KH, Maslankowski L, Hoesley C, Justman J, et al. (2006) Safety and acceptability of celulose sulfate as a vaginal microbicide in HIV-infected women. AIDS 20: 1109-1116.
5. Mayer KH, Maslankowski LA, Gai F, (2006) Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS 20: 543-551.
6. Jespers VA, Van Roey JM, Beets GI, Buvé AM, (2007) Dose-ranging phase 1 study of TMC120, a promising vaginal microbicide, in HIV-negative and HIV-positive female volunteers. J Acquir Immune Defic Syndr 44: 154-158.
7. Ramjee G, Morar NS, Braunsten S, Friedland B, Jones H, et al. (2007) Acceptability of Carraguard, a candidate microbicide, and methylcellulose placebo vaginal gels among HIV-positive women and men in Durban, South Africa. AIDS Res Ther 4: 20 doi:10.1186/1742-6405-4-20.
8. Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, et al. (2008) Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health 17: 383-392.
9. Morrow KM, Ruiz MS, (2008) Assessing microbicide acceptability: A comprehensive and integrated approach. AIDS Behav 12: 272-283.
10. Skoler-Karpoff S, Ramjee G, Ahmed K, Altini L, Plegianos MG, et al. (2008) Efficacy of Carraguard® for prevention of HIV infection among women in South Africa: a randomized, placebo-controlled trial. Lancet 372: 1932-1933.
11. Coetzee N, Blanchard K, Ellertson C, Hoosen A, Friedland B, (2001) Acceptability and feasibility of Micralax® applicators and of methylcellulose placebo for large-scale clinical trials of vaginal microbicides. AIDS 15: 1837-1842.
12. McLean C, van de Wijgert J, Jones H, Karon J, Chaikummao S, et al. (2010) HIV-1 Genital shedding and safety of Carraguard use by HIV-1-infected women: A randomized, controlled, cross-over Trial in Thailand. AIDS 24: 717-22.
13. Whitehead SJ, Kilmarx PH, Blanchard K, Manopaiboon C, Chaikimmao S, et al. (2006) Acceptability of Carraguard vaginal gel use among Thai couples. AIDS 20: 2141-2148.
14. Jones HE, Chaikummao S, van de Wijgert JH, Friedland BA, Manopaiboon C, et al. (2009) Acceptability of a carrageenan-based candidate vaginal microbicide and matching placebo: Findings from a Phase II safety trial among women in Chiang Rai, Thailand. J Women's Health 18: 1003-1010.
15. Kilmarx PH, van de Wijgert JH, Chaikummao S, Jones HE, Limakarnjanarat K, et al. (2006) Safety and acceptability of the candidate microbicide Carraguard in Thai women: Findings from a phase II clinical trial. J Acquir Immun Defic Syndr 43: 327-334.
16. Kilmarx PH, Blanchard K, Chaikummao S, Friedland BA, Srivirojana N, et al. (2008) 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: 226-232.
17. Morrow K, Rosen R, Richter L, Emans A, Forbes A, et al. (2003) The acceptability of an investigational vaginal microbicide, PRO 2000 gel, among women in a phase I clinical trial. J Women's Health 12: 655-666.
18. Braunstein S, van de Wijgert J, (2005) Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing. J Women's Health 14: 424-33.
19. Lai BE, Xie YQ, Lavine ML, Szeri AJ, Owen DH, et al. (2008) Dilution of microbicide gels with vaginal fluid and semen simulants: Effect on rheological properties and coating flow. J Pharm Sci 97: 1030-1038.
20. Owen DH, Peters JJ, Kieweg SL, Geonotti AR, Schnaare RL, et al. (2007) Biophysical analysis of prototype microbicide gels. J Pharm Sci 96: 661-669.
21. Mauck C, Rosenberg Z, van Damme L, for the International Working Group on Microbicides (2001) Recommendations for the clinical development of topical microbicides - an update. AIDS 15: 857-868.
22. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, et al. (2010) Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329: 1168-1174.