MTN Publications | Microbicide Trials Network

Estimating the efficacy of preexposure prophylaxis for HIV prevention among participants with a threshold level of drug concentration.

Dai JY, Gilbert PB, Hughes JP, Brown ER. Estimating the efficacy of preexposure prophylaxis for HIV prevention among participants with a threshold level of drug concentration. Am J Epidemiol 2013 Feb 1;177(3):256-63. PMCID:PMC3577049

A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007).

McGowan I, Hoesley C, Cranston RD, Andrew P, Janocko L, Dai JY, Carballo-Dieguez A, Ayudhya RK, Piper J, Hladik F, Mayer K. A phase 1 randomized, double blind, placebo controlled rectal safety and acceptability study of tenofovir 1% gel (MTN-007). PLoS One 2013;8(4):e60147. PMCID:PMC3616022

MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.

Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One 2013;8(1):e55013. PMCID:PMC3559346

Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial.

Dezzutti CS, Richardson BA, Marrazzo JM, Tugetman J, Ramjee G, Taha T, Chirenje ZM, Abdool Karim SS, Hillier SL, Herold BC. Mucosal Escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial. J Infect Dis 2012 Dec 15;206(12):1931-5. PMCID:PMC3502373

RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate.

Anton PA, Cranston RD, Kashuba A, Hendrix CW, Bumpus NN, Richardson-Harman N, Elliott J, Janocko L, Khanukhova E, Dennis R, Cumberland WG, Ju C, Carballo-Diéguez A, Mauck C, McGowan I. RMP-02/MTN-006: A phase 1 rectal safety, acceptability, pharmacokinetic, and pharmacodynamic study of tenofovir 1% gel compared with oral tenofovir disoproxil fumarate. AIDS Res Hum Retroviruses 2012 Nov;28(11):1412-21. PMCID:PMC3484811

"Tell Juliana": acceptability of the candidate microbicide VivaGel(R) and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study.

Carballo-Dieguez A, Giguere R, Dolezal C, Chen BA, Kahn J, Zimet G, Mabragana M, Leu CS, McGowan I. "Tell Juliana": acceptability of the candidate microbicide VivaGel(R) and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study. AIDS Behav 2012 Oct;16(7):1761-74. PMCID:PMC3272128

Reformulated tenofovir gel for use as a dual compartment microbicide.

Dezzutti CS, Rohan LC, Wang L, Uranker K, Shetler C, Cost M, Lynam JD, Friend D. Reformulated tenofovir gel for use as a dual compartment microbicide. J Antimicrob Chemother 2012 Sep;67(9):2139-42. PMCID:PMC3417689

Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel.

Chirenje ZM, Masse BR, Maslankowski LA, Ramjee G, Coletti AS, Tembo TN, Magure TM, Soto-Torres L, Kelly C, Hillier S, Karim A. Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel. J Int AIDS Soc 2012 Aug 27;15(2):17376. PMCID:PMC3494172

Impact of Pill Sharing on Drug Resistance Due to a Wide-Scale Oral Prep Intervention in Generalized Epidemics.

Dimitrov D, Boily MC, Masse BR, Brown ER. Impact of Pill Sharing on Drug Resistance Due to a Wide-Scale Oral Prep Intervention in Generalized Epidemics. J AIDS Clin Res 2012 Jul 8;Suppl 5(4). PMCID:PMC3870903

Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections.

Cosentino LA, Campbell T, Jett A, Macio I, Zamborsky T, Cranston RD, Hillier SL. Use of nucleic acid amplification testing for diagnosis of anorectal sexually transmitted infections. J Clin Microbiol 2012 Jun;50(6):2005-8. PMCID:PMC3372150

Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe.

Woodsong C, Alleman P, Musara P, Chandipwisa A, Chirenje M, Martinson F, Hoffman I. Preventive misconception as a motivation for participation and adherence in microbicide trials: evidence from female participants and male partners in Malawi and Zimbabwe. AIDS Behav 2012 Apr;16(3):785-90. PMCID:PMC3658446

Partially hidden Markov model for time-varying principal stratification in HIV prevention trials.

Dai JY, Gilbert PB, Masse BR. Partially hidden Markov model for time-varying principal stratification in HIV prevention trials. J Am Stat Assoc 2012 Mar 1;107(497):52-65. PMCID:PMC3649016

Testing of viscous anti-HIV microbicides using Lactobacillus.

Moncla BJ, Pryke K, Rohan LC, Yang H. Testing of viscous anti-HIV microbicides using Lactobacillus. J Microbiol Methods 2012 Feb;88(2):292-6. PMCID:PMC3271802

Variations in microbicide gel acceptability among young women in the USA and Puerto Rico.

Giguere R, Carballo-Dieguez A, Ventuneac A, Mabragana M, Dolezal C, Chen BA, Kahn JA, Zimet GD, McGowan I. Variations in microbicide gel acceptability among young women in the USA and Puerto Rico. Health Sex 2012;14(2):151-66. PMCID:PMC3265079

Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity.

Dezzutti CS, Brown ER, Moncla B, Russo J, Cost M, Wang L, Uranker K, Kunjara Na Ayudhya RP, Pryke K, Pickett J, Leblanc MA, Rohan LC. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One 2012;7(11):e48328. PMCID:PMC3492332

Degradation of naturally occurring and engineered antimicrobial peptides by proteases.

Moncla BJ, Pryke K, Rohan LC, Graebing PW. Degradation of naturally occurring and engineered antimicrobial peptides by proteases. Adv Biosci Biotechnol 2011 Dec;2(6):404-8. PMCID:PMC3354962

Interventions to prevent sexually transmitted infections, including HIV infection.

Marrazzo JM, Cates W. Interventions to prevent sexually transmitted infections, including HIV infection. Clin Infect Dis 2011 Dec;53 Suppl 3:S64-S78. PMCID:PMC3213401

The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention.

Boily MC, Dimitrov D, Abdool Karim SS, Masse B. The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention. Sex Transm Infect 2011 Dec;87(7):646-53. PMCID:PMC3332062

Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy.

Beigi R, Noguchi L, Parsons T, Macio I, Kunjara Na Ayudhya RP, Chen J, Hendrix CW, Masse B, Valentine M, Piper J, Watts DH. Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy. J Infect Dis 2011 Nov 15;204(10):1527-31. PMCID:PMC3192189

Modeling the gender-specific impact of vaginal microbicides on HIV transmission.

Dimitrov DT, Boily MC, Baggaley RF, Masse B. Modeling the gender-specific impact of vaginal microbicides on HIV transmission. Theor Biol 2011 Nov 7;288:9-20. PMCID:PMC3184649

Oral antiretroviral pre-exposure prophylaxis reduces the risk of HIV acquisition among men who have sex with men.

Boily MC, Masse BR, Dimitrov D. Oral antiretroviral pre-exposure prophylaxis reduces the risk of HIV acquisition among men who have sex with men. Evid Based Med 2011 Oct;16(5):146-7. PMCID:PMC3480078

Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators.

Dezzutti CS, Hendrix CW, Marrazzo JM, Pan Z, Wang L, Louissaint N, Kalyoussef S, Torres NM, Hladik F, Parikh U, Mellors J, Hillier SL, Herold BC. Performance of swabs, lavage, and diluents to quantify biomarkers of female genital tract soluble mucosal mediators. PLoS One 2011;6(8):e23136. PMCID:PMC3155537

LabKey Server NAb: a tool for analyzing, visualizing and sharing results from neutralizing antibody assays.

Piehler B, Nelson EK, Eckels J, Ramsay S, Lum K, Wood B, Greene KM, Gao H, Seaman MS, Montefiori DC, Igra M. LabKey Server NAb: a tool for analyzing, visualizing and sharing results from neutralizing antibody assays. BMC Immunol 2011 May 27;12:33. PMCID:PMC3115917

Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004).

McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS 2011 May 15;25(8):1057-64. PMCID:PMC3103767

Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women.

Abdool Karim SS, Richardson BA, Ramjee G, Hoffman IF, Chirenje ZM, Taha T, Kapina M, Maslankowski L, Coletti A, Profy A, Moench TR, Piwowar-Manning E, Masse B, Hillier SL, Soto-Torres L. Safety and effectiveness of BufferGel and 0.5% PRO2000 gel for the prevention of HIV infection in women. AIDS 2011 Apr 24;25(7):957-66. PMCID:PMC3083640

Factors influencing the emergence and spread of HIV drug resistance arising from rollout of antiretroviral pre-exposure prophylaxis (PrEP).

Abbas UL, Hood G, Wetzel AW, Mellors JW. Factors influencing the emergence and spread of HIV drug resistance arising from rollout of antiretroviral pre-exposure prophylaxis (PrEP). PLoS One 2011 Apr 15;6(4):e18165. PMCID:PMC3078109

LabKey Server: an open source platform for scientific data integration, analysis and collaboration.

Nelson EK, Piehler B, Eckels J, Rauch A, Bellew M, Hussey P, Ramsay S, Nathe C, Lum K, Krouse K, Stearns D, Connolly B, Skillman T, Igra M. LabKey Server: an open source platform for scientific data integration, analysis and collaboration. BMC Bioinformatics 2011 Mar 9;12:71. PMCID:PMC3062597

Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks.

Rosas SR, Kagan JM, Schouten JT, Slack PA, Trochim WM. Evaluating research and impact: a bibliometric analysis of research by the NIH/NIAID HIV/AIDS clinical trials networks. PLoS One 2011 Mar 4;6(3):e17428. PMCID:PMC3048860

Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

White R, Chileshe M, Dawson L, Donnell D, Hillier S, Morar N, Noguchi L, Dixon D. Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa. Clin Trials 2011 Feb;8(1):103-11. PMCID:PMC3478774

A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel.

Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One 2011 Jan 25;6(1):e16475. PMCID:PMC3026837

Good intentions: risk factors for unintended pregnancies in the US cohort of a microbicide trial.

Schreiber CA, Whittington S, Cen L, Maslankowski L. Good intentions: risk factors for unintended pregnancies in the US cohort of a microbicide trial. Contraception 2011 Jan;83(1):74-81

Antiretroviral-based HIV prevention strategies for women.

Chirenje ZM, Marrazzo J, Parikh UM. Antiretroviral-based HIV prevention strategies for women. Expert Rev Anti Infect Ther 2010 Oct;8(10):1177-86. PMCID: PMC4381115

Validation of rapid HIV antibody tests in 5 African countries.

Piwowar-Manning EM, Tustin NB, Sikateyo P, Kamwendo D, Chipungu C, Maharaj R, Mushanyu J, Richardson BA, Hillier S, Brooks JJ. Validation of rapid HIV antibody tests in 5 African countries. J Int Assoc Physicians AIDS Care (Chic ) 2010 May-Jun;9(3):170-2. PMCID:PMC2989535

In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide.

Rohan LC, Moncla BJ, Kunjara Na Ayudhya RP, Cost M, Huang Y, Gai F, Billitto N, Lynam JD, Pryke K, Graebing P, Hopkins N, Rooney JF, Friend D, Dezzutti CS. In vitro and ex vivo testing of tenofovir shows it is effective as an HIV-1 microbicide. PLoS One 2010 Feb 19;5(2):e9310. PMCID:PMC2824823

Efficacy dilution in randomized placebo-controlled vaginal microbicide trials.

Masse BR, Boily MC, Dimitrov D, Desai K. Efficacy dilution in randomized placebo-controlled vaginal microbicide trials. Emerg Themes Epidemiol 2009 Oct 9;6:5. PMCID:PMC2768687

The role of heterosexual anal intercourse for HIV transmission in developing countries: are we ready to draw conclusions?

Boily MC, Baggaley RF, Masse B. The role of heterosexual anal intercourse for HIV transmission in developing countries: are we ready to draw conclusions? Sex Transm Infect 2009 Oct;85(6):408-10. PMCID:PMC3395196

Limitations of the dye-based method for determining vaginal applicator use in microbicide trials.

Austin MN, Rabe LK, Hillier SL. Limitations of the dye-based method for determining vaginal applicator use in microbicide trials. Sex Transm Dis 2009 Jun;36(6):368-71. PMCID:PMC2760219

Oleate lipase activity in Gardnerella vaginalis and reconsideration of existing biotype schemes.

Moncla BJ, Pryke KM. Oleate lipase activity in Gardnerella vaginalis and reconsideration of existing biotype schemes. BMC Microbiol 2009 Apr 22;9:78. PMCID:PMC2680412

Using mathematical modeling to bridge phase 3 microbicide trials with public health decision making.

Masse BR, Boily MC, Desai K. Using mathematical modeling to bridge phase 3 microbicide trials with public health decision making. J Acquir Immune Defic Syndr 2009 Apr 1;50(4):434-5

A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials.

Schreiber CA, Sammel M, Hillier SL, Barnhart KT. A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials. Am J Epidemiol 2009 Feb 15;169(4):515-21. PMCID:PMC2732971

Heterosexual risk of HIV-1 infection per sexual act: systematic review and meta-analysis of observational studies.

Boily MC, Baggaley RF, Wang L, Masse B, White RG, Hayes RJ, Alary M. Heterosexual risk of HIV-1 infection per sexual act: systematic review and meta-analysis of observational studies. Lancet Infect Dis 2009 Feb;9(2):118-29. PMCID: PMC4467783

Topical microbicides to prevent HIV: clinical drug development challenges.

Hendrix CW, Cao YJ, Fuchs EJ. Topical microbicides to prevent HIV: clinical drug development challenges. Annu Rev Pharmacol Toxicol 2009;49:349-75

Incremental role of male circumcision on a generalised HIV epidemic through its protective effect against other sexually transmitted infections: from efficacy to effectiveness to population-level impact.

Boily MC, Desai K, Masse B, Gumel A. Incremental role of male circumcision on a generalised HIV epidemic through its protective effect against other sexually transmitted infections: from efficacy to effectiveness to population-level impact. Sex Transm Infect 2008 Oct;84 Suppl 2:ii28-ii34. PMCID:PMC3423078

Can a topical microbicide prevent rectal HIV transmission?

Hladik F, Dezzutti CS. Can a topical microbicide prevent rectal HIV transmission? PLoS Med 2008 Aug 5;5(8):e167. PMCID:PMC2494564

Quantitative survival of aerobic and anaerobic microorganisms in Port-A-Cul and Copan transport systems.

Stoner KA, Rabe LK, Austin MN, Meyn LA, Hillier SL. Quantitative survival of aerobic and anaerobic microorganisms in Port-A-Cul and Copan transport systems. J Clin Microbiol 2008 Aug;46(8):2739-44. PMCID:PMC2519491

Biological and technical variables affecting immunoassay recovery of cytokines from human serum and simulated vaginal fluid: a multicenter study.

Fichorova RN, Richardson-Harman N, Alfano M, Belec L, Carbonneil C, Chen S, Cosentino L, Curtis K, Dezzutti CS, Donoval B, Doncel GF, Donaghay M, Grivel JC, Guzman E, Hayes M, Herold B, Hillier S, Lackman-Smith C, Landay A, Margolis L, Mayer KH, Pasicznyk JM, Pallansch-Cokonis M, Poli G, Reichelderfer P, Roberts P, Rodriguez I, Saidi H, Sassi RR, Shattock R, Cummins JE Jr. Biological and technical variables affecting immunoassay recovery of cytokines from human serum and simulated vaginal fluid: a multicenter study. Anal Chem 2008 Jun 15;80(12):4741-51. PMCID:PMC2646866