메뉴 건너뛰기




Volumn 6, Issue 1, 2011, Pages

A phase I randomized placebo controlled trial of the safety of 3% SPL7013 gel (VivaGel®) in healthy young women administered twice daily for 14 days

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; PLACEBO; VIVAGEL; ANTIINFECTIVE AGENT; POLYLYSINE;

EID: 79251604177     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0016258     Document Type: Article
Times cited : (72)

References (26)
  • 1
    • 84885466560 scopus 로고    scopus 로고
    • Joint United Nations Programme on HIV/AIDS
    • UNAIDS
    • UNAIDS (2008) Joint United Nations Programme on HIV/AIDS. Report on the global AIDS epidemic.
    • (2008) Report on the global AIDS epidemic
  • 3
    • 0033017798 scopus 로고    scopus 로고
    • From epidemiological synergy to public health policy and practice: The contribution of other sexually transmitted diseases to sexual transmission of HIV infection
    • Fleming DT, Wasserheit JN (1999) From epidemiological synergy to public health policy and practice: the contribution of other sexually transmitted diseases to sexual transmission of HIV infection. Sex Transm Infect 75: 3-17.
    • (1999) Sex Transm Infect , vol.75 , pp. 3-17
    • Fleming, D.T.1    Wasserheit, J.N.2
  • 4
    • 27744509732 scopus 로고    scopus 로고
    • Evaluation of dendrimer SPL7013, a lead microbicide candidate against herpes simplex viruses
    • Gong E, Matthews B, McCarthy T, Chu J, Holan G, et al. (2005) Evaluation of dendrimer SPL7013, a lead microbicide candidate against herpes simplex viruses. Antiviral Res 68: 139-146.
    • (2005) Antiviral Res , vol.68 , pp. 139-146
    • Gong, E.1    Matthews, B.2    McCarthy, T.3    Chu, J.4    Holan, G.5
  • 5
    • 0141516252 scopus 로고    scopus 로고
    • Poly(sodium 4-styrene sulfonate): Evaluation of a topical microbicide gel against herpes simplex virus type 2 and Chlamydia trachomatis infections in mice
    • Bourne N, Zaneveld LJ, Ward JA, Ireland JP, Stanberry LR (2003) Poly(sodium 4-styrene sulfonate): evaluation of a topical microbicide gel against herpes simplex virus type 2 and Chlamydia trachomatis infections in mice. Clin Microbiol Infect 9: 816-822.
    • (2003) Clin Microbiol Infect , vol.9 , pp. 816-822
    • Bourne, N.1    Zaneveld, L.J.2    Ward, J.A.3    Ireland, J.P.4    Stanberry, L.R.5
  • 6
    • 4644225675 scopus 로고    scopus 로고
    • In vitro comparison of topical microbicides for prevention of human immunodeficiency virus type 1 transmission
    • Dezzutti C, James V, Ramos A, Sullivan S, Siddig A, et al. (2004) In vitro comparison of topical microbicides for prevention of human immunodeficiency virus type 1 transmission. Antimicrob Agents Chemother 48: 3834-3844.
    • (2004) Antimicrob Agents Chemother , vol.48 , pp. 3834-3844
    • Dezzutti, C.1    James, V.2    Ramos, A.3    Sullivan, S.4    Siddig, A.5
  • 7
    • 0036298609 scopus 로고    scopus 로고
    • Evidence of dual sites of action of dendrimers: SPL-2999 inhibits both virus entry and late stages of herpes simplex virus replication
    • Gong Y, Matthews B, Cheung D, Tam T, Gadawski I, et al. (2002) Evidence of dual sites of action of dendrimers: SPL-2999 inhibits both virus entry and late stages of herpes simplex virus replication. Antiviral Res 55: 319-329.
    • (2002) Antiviral Res , vol.55 , pp. 319-329
    • Gong, Y.1    Matthews, B.2    Cheung, D.3    Tam, T.4    Gadawski, I.5
  • 8
    • 0033792661 scopus 로고    scopus 로고
    • Polyanionic (i.e., polysulfonate) dendrimers can inhibit the replication of human immunodeficiency virus by interfering with both virus adsorption and later steps (reverse transcriptase/integrase) in the virus replicative cycle
    • Witvrouw M, Fikkert V, Pluymers W, Matthews B, Mardel K, et al. (2000) Polyanionic (i.e., polysulfonate) dendrimers can inhibit the replication of human immunodeficiency virus by interfering with both virus adsorption and later steps (reverse transcriptase/integrase) in the virus replicative cycle. Mol Pharmacol 58: 1100-1108.
    • (2000) Mol Pharmacol , vol.58 , pp. 1100-1108
    • Witvrouw, M.1    Fikkert, V.2    Pluymers, W.3    Matthews, B.4    Mardel, K.5
  • 9
    • 33646449167 scopus 로고    scopus 로고
    • Preclinical safety and efficacy assessments of dendrimer-based (SPL7013) microbicide gel formulations in a nonhuman primate model
    • Patton DL, Cosgrove Sweeney YT, McCarthy TD, Hillier SL (2006) Preclinical safety and efficacy assessments of dendrimer-based (SPL7013) microbicide gel formulations in a nonhuman primate model. Antimicrob Agents Chemother 50: 1696-1700.
    • (2006) Antimicrob Agents Chemother , vol.50 , pp. 1696-1700
    • Patton, D.L.1    Cosgrove Sweeney, Y.T.2    McCarthy, T.D.3    Hillier, S.L.4
  • 10
    • 77649116837 scopus 로고    scopus 로고
    • Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): A dose ranging, phase I study
    • O'Loughlin J, Millwood IY, McDonald HM, Price CF, Kaldor JM, et al. (2009) Safety, tolerability, and pharmacokinetics of SPL7013 gel (VivaGel): a dose ranging, phase I study. Sex Transm Dis 37: 100-104.
    • (2009) Sex Transm Dis , vol.37 , pp. 100-104
    • O'Loughlin, J.1    Millwood, I.Y.2    McDonald, H.M.3    Price, C.F.4    Kaldor, J.M.5
  • 11
    • 0035805179 scopus 로고    scopus 로고
    • Recommendations for the clinical development of topical microbicides: An update
    • Mauck C, Rosenberg Z, Van Damme L (2001) Recommendations for the clinical development of topical microbicides: an update. AIDS 15: 857-868.
    • (2001) AIDS , vol.15 , pp. 857-868
    • Mauck, C.1    Rosenberg, Z.2    Van Damme, L.3
  • 12
    • 79251606689 scopus 로고    scopus 로고
    • Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products
    • CONRAD/WHO
    • CONRAD/WHO (2004) Manual for the Standardization of Colposcopy for the Evaluation of Vaginal Products. Update 2004.
    • (2004) Update 2004
  • 13
    • 0026088584 scopus 로고
    • Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation
    • Nugent R, Krohn M, Hillier S (1991) Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 29: 297-301.
    • (1991) J Clin Microbiol , vol.29 , pp. 297-301
    • Nugent, R.1    Krohn, M.2    Hillier, S.3
  • 14
    • 34547620841 scopus 로고    scopus 로고
    • Selfreported mechanical problems during condom use and semen exposure. Comparison of two randomized trials in the United States of America and Brazil
    • Chen M, Macaluso M, Blackwell R, Galvao L, Kulczycki A, et al. (2007) Selfreported mechanical problems during condom use and semen exposure. Comparison of two randomized trials in the United States of America and Brazil. Sex Transm Dis 34: 557-562.
    • (2007) Sex Transm Dis , vol.34 , pp. 557-562
    • Chen, M.1    Macaluso, M.2    Blackwell, R.3    Galvao, L.4    Kulczycki, A.5
  • 15
    • 34250743515 scopus 로고    scopus 로고
    • Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials
    • Wallace A, Teitelbaum A, Wan L, Mulima M, Guichard L, et al. (2007) Determining the feasibility of utilizing the microbicide applicator compliance assay for use in clinical trials. Contraception 76: 53-56.
    • (2007) Contraception , vol.76 , pp. 53-56
    • Wallace, A.1    Teitelbaum, A.2    Wan, L.3    Mulima, M.4    Guichard, L.5
  • 16
    • 34547618048 scopus 로고    scopus 로고
    • Detection and quantification of Y-chromosomal sequences by real-time PCR using the LightCycler system
    • Melendez J, Giles J, Yuenger J, Smith T, Ghanem K, et al. (2007) Detection and quantification of Y-chromosomal sequences by real-time PCR using the LightCycler system. Sex Transm Dis 34: 617-619.
    • (2007) Sex Transm Dis , vol.34 , pp. 617-619
    • Melendez, J.1    Giles, J.2    Yuenger, J.3    Smith, T.4    Ghanem, K.5
  • 17
    • 79251633821 scopus 로고    scopus 로고
    • A Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 (VivaGel) Applied Vaginally in Sexually Active Young Women (MTN-004)
    • Pittsburgh, PA
    • McGowan I, Gomez K, Emmanuel P, Febo I, Chen BA, et al. (2010) A Phase I Study of the Safety and Acceptability of 3% w/w SPL7013 (VivaGel) Applied Vaginally in Sexually Active Young Women (MTN-004). Microbicides 2010. Pittsburgh, PA.
    • (2010) Microbicides 2010
    • McGowan, I.1    Gomez, K.2    Emmanuel, P.3    Febo, I.4    Chen, B.A.5
  • 18
    • 77955430749 scopus 로고    scopus 로고
    • Increased levels of immune activation in the genital tract of healthy young women from sub- Saharan Africa
    • Cohen C, Moscicki A, Scott M, Ma Y, Shiboski S, et al. (2010) Increased levels of immune activation in the genital tract of healthy young women from sub- Saharan Africa. AIDS 24: 2069-2074.
    • (2010) AIDS , vol.24 , pp. 2069-2074
    • Cohen, C.1    Moscicki, A.2    Scott, M.3    Ma, Y.4    Shiboski, S.5
  • 19
    • 0036848251 scopus 로고    scopus 로고
    • Safety of single daily use for one week of C31G HEC gel in women
    • Ballagh SA, Baker JM, Henry DM, Archer DF (2002) Safety of single daily use for one week of C31G HEC gel in women. Contraception 66: 369-375.
    • (2002) Contraception , vol.66 , pp. 369-375
    • Ballagh, S.A.1    Baker, J.M.2    Henry, D.M.3    Archer, D.F.4
  • 20
    • 7744236494 scopus 로고    scopus 로고
    • Nonoxynol-9 100 mg gel: Multi-site safety study from sub-Saharan Africa
    • Hoffman IF, Taha TE, Padian NS, Kelly CW, Welch JD, et al. (2004) Nonoxynol-9 100 mg gel: multi-site safety study from sub-Saharan Africa. AIDS 18: 2191-2195.
    • (2004) AIDS , vol.18 , pp. 2191-2195
    • Hoffman, I.F.1    Taha, T.E.2    Padian, N.S.3    Kelly, C.W.4    Welch, J.D.5
  • 21
    • 27944510206 scopus 로고    scopus 로고
    • Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel
    • Malonza IM, Mirembe F, Nakabiito C, Odusoga LO, Osinupebi OA, et al. (2005) Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel. AIDS 19: 2157-2163.
    • (2005) AIDS , vol.19 , pp. 2157-2163
    • Malonza, I.M.1    Mirembe, F.2    Nakabiito, C.3    Odusoga, L.O.4    Osinupebi, O.A.5
  • 22
    • 4344602905 scopus 로고    scopus 로고
    • A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II
    • Mauck CK, Weiner DH, Creinin MD, Barnhart KT, Callahan MM, et al. (2004) A randomized Phase I vaginal safety study of three concentrations of C31G vs. Extra Strength Gynol II. Contraception 70: 233-240.
    • (2004) Contraception , vol.70 , pp. 233-240
    • Mauck, C.K.1    Weiner, D.H.2    Creinin, M.D.3    Barnhart, K.T.4    Callahan, M.M.5
  • 23
    • 0035112881 scopus 로고    scopus 로고
    • Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States
    • Mayer KH, Peipert J, Fleming T, Fullem A, Moench T, et al. (2001) Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis 32: 476-482.
    • (2001) Clin Infect Dis , vol.32 , pp. 476-482
    • Mayer, K.H.1    Peipert, J.2    Fleming, T.3    Fullem, A.4    Moench, T.5
  • 24
    • 33745948610 scopus 로고    scopus 로고
    • Fourteenday safety and acceptability study of 6% cellulose sulfate gel: A randomized double-blind Phase I safety study
    • Schwartz JL, Mauck C, Lai JJ, Creinin MD, Brache V, et al. (2006) Fourteenday safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception 74: 133-140.
    • (2006) Contraception , vol.74 , pp. 133-140
    • Schwartz, J.L.1    Mauck, C.2    Lai, J.J.3    Creinin, M.D.4    Brache, V.5
  • 25
    • 0035144537 scopus 로고    scopus 로고
    • Phase 1 trial of the topical microbicide BufferGel: Safety results from four international sites
    • van De Wijgert J, Fullem A, Kelly C, Mehendale S, Rugpao S, et al. (2001) Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr 26: 21-27.
    • (2001) J Acquir Immune Defic Syndr , vol.26 , pp. 21-27
    • van de Wijgert, J.1    Fullem, A.2    Kelly, C.3    Mehendale, S.4    Rugpao, S.5
  • 26
    • 38549116136 scopus 로고    scopus 로고
    • Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials
    • van de Wijgert JH, Kilmarx PH, Jones HE, Karon JM, Chaikummao S (2008) Differentiating normal from abnormal rates of genital epithelial findings in vaginal microbicide trials. Contraception 77: 122-129.
    • (2008) Contraception , vol.77 , pp. 122-129
    • van de Wijgert, J.H.1    Kilmarx, P.H.2    Jones, H.E.3    Karon, J.M.4    Chaikummao, S.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.