The Experts below are selected from a list of 6621 Experts worldwide ranked by ideXlab platform

Shibo Jiang - One of the best experts on this subject based on the ideXlab platform.

  • ADS-J1 Inhibits Semen-Derived Amyloid Fibril Formation and Blocks Fibril-Mediated Enhancement of HIV-1 Infection
    2016
    Co-Authors: Shibo Jiang, Suiyi A Tan, Shuwen A Liua
    Abstract:

    Semen-derived enhancer of viral infection (SEVI) is composed of amyloid fibrils that can greatly enhance HIV-1 infectivity. By its cationic property, SEVI promotes viral sexual transmission by facilitating the attachment and internalization of HIV-1 to target cells. Therefore, semen-derived amyloid fibrils are potential targets for microbicide design. ADS-J1 is an anionic HIV-1 entry inhibitor. In this study, we explored an additional function of ADS-J1: inhibition of SEVI fibril formation and blockage of SEVI-mediated enhancement of viral infection. We found that ADS-J1 bound to an amyloidogenic peptide fragment (PAP248–286, comprising amino acids 248 to 286 of the enzyme prostatic acid phosphatase), thereby inhibiting peptide assembly into amyloid fibrils. In addition, ADS-J1 binds to mature amyloid fibrils and antagonizes fibril-mediated enhancement of viral infection. Un-like Cellulose Sulfate, a polyanion that failed in clinical trial to prevent HIV-1 sexual transmission, ADS-J1 shows no ability to facilitate fibril formation. More importantly, the combination of ADS-J1 with several antiretroviral drugs exhibited synergistic effects against HIV-1 infection in semen, with little cytotoxicity to vaginal epithelial cells. Our results suggest that ADS-J1 or a derivative may be incorporated into a combinationmicrobicide for prevention of the sexual transmission of HIV-1. According to the latest report on the global AIDS epidemic,published in 2013, 2.3 million new HIV-1 infections were reportedworldwide in 2012, and sexual contact remains themajo

  • Polyanionic Candidate Microbicides Accelerate the Formation of Semen-Derived Amyloid Fibrils to Enhance HIV-1 Infection
    2016
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluatin

  • ads j1 inhibits semen derived amyloid fibril formation and blocks fibril mediated enhancement of hiv 1 infection
    Antimicrobial Agents and Chemotherapy, 2015
    Co-Authors: Tianrong Xun, Suiyi Tan, Shibo Jiang, Jinquan Chen, Qian Wang, Xuefeng Zhou, Shuwen Liu
    Abstract:

    Semen-derived enhancer of viral infection (SEVI) is composed of amyloid fibrils that can greatly enhance HIV-1 infectivity. By its cationic property, SEVI promotes viral sexual transmission by facilitating the attachment and internalization of HIV-1 to target cells. Therefore, semen-derived amyloid fibrils are potential targets for microbicide design. ADS-J1 is an anionic HIV-1 entry inhibitor. In this study, we explored an additional function of ADS-J1: inhibition of SEVI fibril formation and blockage of SEVI-mediated enhancement of viral infection. We found that ADS-J1 bound to an amyloidogenic peptide fragment (PAP248-286, comprising amino acids 248 to 286 of the enzyme prostatic acid phosphatase), thereby inhibiting peptide assembly into amyloid fibrils. In addition, ADS-J1 binds to mature amyloid fibrils and antagonizes fibril-mediated enhancement of viral infection. Unlike Cellulose Sulfate, a polyanion that failed in clinical trial to prevent HIV-1 sexual transmission, ADS-J1 shows no ability to facilitate fibril formation. More importantly, the combination of ADS-J1 with several antiretroviral drugs exhibited synergistic effects against HIV-1 infection in semen, with little cytotoxicity to vaginal epithelial cells. Our results suggest that ADS-J1 or a derivative may be incorporated into a combination microbicide for prevention of the sexual transmission of HIV-1.

  • polyanionic candidate microbicides accelerate the formation of semen derived amyloid fibrils to enhance hiv 1 infection
    PLOS ONE, 2013
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluating the anti-HIV-1 efficacy of candidate microbicides.

Shuwen Liu - One of the best experts on this subject based on the ideXlab platform.

  • Polyanionic Candidate Microbicides Accelerate the Formation of Semen-Derived Amyloid Fibrils to Enhance HIV-1 Infection
    2016
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluatin

  • ads j1 inhibits semen derived amyloid fibril formation and blocks fibril mediated enhancement of hiv 1 infection
    Antimicrobial Agents and Chemotherapy, 2015
    Co-Authors: Tianrong Xun, Suiyi Tan, Shibo Jiang, Jinquan Chen, Qian Wang, Xuefeng Zhou, Shuwen Liu
    Abstract:

    Semen-derived enhancer of viral infection (SEVI) is composed of amyloid fibrils that can greatly enhance HIV-1 infectivity. By its cationic property, SEVI promotes viral sexual transmission by facilitating the attachment and internalization of HIV-1 to target cells. Therefore, semen-derived amyloid fibrils are potential targets for microbicide design. ADS-J1 is an anionic HIV-1 entry inhibitor. In this study, we explored an additional function of ADS-J1: inhibition of SEVI fibril formation and blockage of SEVI-mediated enhancement of viral infection. We found that ADS-J1 bound to an amyloidogenic peptide fragment (PAP248-286, comprising amino acids 248 to 286 of the enzyme prostatic acid phosphatase), thereby inhibiting peptide assembly into amyloid fibrils. In addition, ADS-J1 binds to mature amyloid fibrils and antagonizes fibril-mediated enhancement of viral infection. Unlike Cellulose Sulfate, a polyanion that failed in clinical trial to prevent HIV-1 sexual transmission, ADS-J1 shows no ability to facilitate fibril formation. More importantly, the combination of ADS-J1 with several antiretroviral drugs exhibited synergistic effects against HIV-1 infection in semen, with little cytotoxicity to vaginal epithelial cells. Our results suggest that ADS-J1 or a derivative may be incorporated into a combination microbicide for prevention of the sexual transmission of HIV-1.

  • polyanionic candidate microbicides accelerate the formation of semen derived amyloid fibrils to enhance hiv 1 infection
    PLOS ONE, 2013
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluating the anti-HIV-1 efficacy of candidate microbicides.

Suiyi Tan - One of the best experts on this subject based on the ideXlab platform.

  • Polyanionic Candidate Microbicides Accelerate the Formation of Semen-Derived Amyloid Fibrils to Enhance HIV-1 Infection
    2016
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluatin

  • ads j1 inhibits semen derived amyloid fibril formation and blocks fibril mediated enhancement of hiv 1 infection
    Antimicrobial Agents and Chemotherapy, 2015
    Co-Authors: Tianrong Xun, Suiyi Tan, Shibo Jiang, Jinquan Chen, Qian Wang, Xuefeng Zhou, Shuwen Liu
    Abstract:

    Semen-derived enhancer of viral infection (SEVI) is composed of amyloid fibrils that can greatly enhance HIV-1 infectivity. By its cationic property, SEVI promotes viral sexual transmission by facilitating the attachment and internalization of HIV-1 to target cells. Therefore, semen-derived amyloid fibrils are potential targets for microbicide design. ADS-J1 is an anionic HIV-1 entry inhibitor. In this study, we explored an additional function of ADS-J1: inhibition of SEVI fibril formation and blockage of SEVI-mediated enhancement of viral infection. We found that ADS-J1 bound to an amyloidogenic peptide fragment (PAP248-286, comprising amino acids 248 to 286 of the enzyme prostatic acid phosphatase), thereby inhibiting peptide assembly into amyloid fibrils. In addition, ADS-J1 binds to mature amyloid fibrils and antagonizes fibril-mediated enhancement of viral infection. Unlike Cellulose Sulfate, a polyanion that failed in clinical trial to prevent HIV-1 sexual transmission, ADS-J1 shows no ability to facilitate fibril formation. More importantly, the combination of ADS-J1 with several antiretroviral drugs exhibited synergistic effects against HIV-1 infection in semen, with little cytotoxicity to vaginal epithelial cells. Our results suggest that ADS-J1 or a derivative may be incorporated into a combination microbicide for prevention of the sexual transmission of HIV-1.

  • polyanionic candidate microbicides accelerate the formation of semen derived amyloid fibrils to enhance hiv 1 infection
    PLOS ONE, 2013
    Co-Authors: Suiyi Tan, Jixiang Liu, Yelena Oksov, Shibo Jiang, Shuwen Liu
    Abstract:

    Polyanionic candidate microbicides, including Cellulose Sulfate, carrageenan, PRO 2000, were proven ineffective in preventing HIV-1 transmission and even Cellulose Sulfate showed increased risk of HIV acquisition in the Phase III efficacy trials. Semen plays critical roles in HIV-1 sexual transmission. Specifically, amyloid fibrils formed by fragments of prostatic acidic phosphatase (PAP) in semen termed semen-derived enhancer of virus infection (SEVI) could drastically enhance HIV-1 infection. Here we investigated the interaction between polyanions and PAP248-286, a prototype peptide of SEVI, to understand the possible cause of polyanionic candidate microbicides to fail in clinical trials. We found anionic polymers could efficiently promote SEVI fibril formation, most likely mediated by the natural electrostatic interaction between polyanions and PAP248-286, as revealed by acid native PAGE and Western blot. The overall anti-HIV-1 activity of polyanions in the presence or absence of PAP248-286 or semen was evaluated. In the viral infection assay, the supernatants of polyanions/PAP248-286 or polyanions/semen mixtures containing the free, unbound polyanionic molecules showed a general reduction in antiviral efficacy, while the pellets containing amyloid fibrils formed by the polyanion-bound PAP248-286 showed aggravated enhancement of viral infection. Collectively, from the point of drug-host protein interaction, our study revealed that polyanions facilitate SEVI fibril formation to promote HIV-1 infection, thus highlighting a molecular mechanism underlying the failure of polyanions in clinical trials and the importance of drug-semen interaction in evaluating the anti-HIV-1 efficacy of candidate microbicides.

Shanjing Yao - One of the best experts on this subject based on the ideXlab platform.

  • sodium Cellulose Sulfate a promising biomaterial used for microcarriers designing
    Frontiers of Chemical Engineering in China, 2019
    Co-Authors: Yixin Guan, Shanjing Yao
    Abstract:

    Due to a worldwide focus on sustainable materials for human health and economy services, more and more natural renewable biomass are regarded as promising materials that could replace synthetic polymers and reduce global dependence on petroleum resources. Cellulose is known as the most abundant renewable polymer in nature, varieties of Cellulose-based products have been developed and have gained growing interest in recent years. In this review, a kind of water-soluble Cellulose derivative, i.e., sodium Cellulose Sulfate (NaCS) is introduced. Details about NaCS’s physicochemical properties like solubility, biocompatibility, biodegradability, degree of substitution, etc. are systematically elaborated. And promising applications of NaCS used as biomaterials for microcarriers’ designing, such as microcell- carriers, micro-drug-carriers, etc., are presented.

  • review on biomedical and bioengineering applications of Cellulose Sulfate
    Carbohydrate Polymers, 2015
    Co-Authors: Qilei Zhang, Dongqiang Lin, Shanjing Yao
    Abstract:

    Polysaccharide Sulfates are naturally existing chemicals that show important biological activities in living organisms. Cellulose Sulfate is a semi-synthesized polysaccharide Sulfate with a relatively simple chain structure and unique biological properties and its biological applications have been explored in research and clinical trials. With the advance of Cellulose derivatization and characterization, Cellulose Sulfate molecules with tailored structures have been developed to fulfill individual requirements. This review aims to provide a summary of recent development of Cellulose Sulfate in biomedical applications. Its synthesis pathways were discussed with structure-property relationship elucidated. The application of Cellulose Sulfate in drug delivery and microbe/cell immobilization were summarized with emphasis given on its polyelectrolyte complex formation processes.

  • novel double walled microspheres based on chitosan sodium Cellulose Sulfate and sodium tripolyphosphate preparation characterization and in vitro release study
    Korean Journal of Chemical Engineering, 2015
    Co-Authors: Shanjing Yao, Liying Zhu, Xiaoqin Yan, Hongman Zhang, Ling Jiang
    Abstract:

    A novel double-walled microsphere composed of chitosan, sodium Cellulose Sulfate (NaCS) and sodium tripolyphosphate (TPP) was prepared. TPP was used as ionic crosslinker. The morphology of the microspheres was observed by microscope and SEM, and the results showed that the double-walled microsphere was smooth outside, with rough interior surface. FTIR spectra analysis was performed to investigate the PEC formation among chitosan, NaCS, and TPP. In vitro release studies of BSA showed that the double-walled microspheres had regular and sustainable release profiles in simulated colonic fluid (SCF). Our results indicated that the double-walled microspheres prepared could be used as a candidate protein drug carrier for the colon.

  • performances of nacs wsc protein drug microcapsules with different degree of substitution of nacs using sodium polyphosphate as cross linking agent
    Cellulose, 2014
    Co-Authors: Shanjing Yao
    Abstract:

    Sodium Cellulose Sulfate–water soluble chitosan (NaCS–WSC) microcapsules loaded with lactoferrin were fabricated with special performances using different degree of substitution (DS) of NaCS and WSC as potential micro-drug-carriers for colon. Effect of using cross-linking agent (sodium polyphosphate) and DS of NaCS on the structures and performances of microcapsules was studied. The results of laser scanning confocal microscope showed that fluorescein isothiocyanate-labeled lactoferrin distributed evenly in the drug-loaded microcapsules with cross-linker. NaCSs (DS: 0.51 and DS: 0.66, respectively) were chosen to prepare lactoferrin loaded microcapsules with WSC and cross-linker for comparison studies. DS of NaCS had some effects on erosion properties in which the erosion ratios of microcapsules with DS of 0.51 were higher than that with DS of 0.66, but showed no effect on swelling behaviors. Drug loading and encapsulation efficiencies of microcapsules (DS: 0.66) were 51.05 ± 0.97 and 75.88 ± 1.44 %, respectively, which were higher than that of microcapsules with DS of 0.51. In vitro release studies showed that the percentage of drug release of microcapsules (DS: 0.51) were higher than that of microcapsules with DS of 0.66 in simulated colonic fluid (pH 6.4) under mechanism of Anomalous (non-Fickian) transport, indicating that they are promising candidates as sustained protein drug delivery carriers with special performances.

  • effect and mechanism of sodium chloride on the formation of chitosan Cellulose Sulfate tripolyphosphate crosslinked beads
    Soft Matter, 2013
    Co-Authors: Qilei Zhang, Dongqiang Lin, Shanjing Yao
    Abstract:

    Chitosan obtained by deacetylation of chitin is the only pseudo-natural cationic polymer and has been widely used for a variety of applications. It can crosslink with small molecules or form polyelectrolyte complexes with polyanions, and these reactions are usually carried out in aqueous solutions under mild conditions without toxic additives or organic solvents, which is beneficial for its application in medical and pharmaceutical industries. However, these reaction processes can be affected by several factors such as charge density, ionic strength and pH. This study investigated the effect of sodium chloride (NaCl) on the formation of chitosan beads composed of chitosan, sodium Cellulose Sulfate (NaCS) and sodium tripolyphosphate (TPP). The results revealed that the bead size was influenced by NaCl and TPP which was mainly due to the osmotic pressure and “salting out” effects. The addition of NaCl in the three-component system led to the formation of chitosan beads without NaCS linked on the surface, which is probably because of the screening effect of NaCl in the solution. Detailed mechanisms were discussed and a model mechanism was proposed.

Christine K Mauck - One of the best experts on this subject based on the ideXlab platform.

  • noncomparative contraceptive efficacy of Cellulose Sulfate gel
    Obstetrics & Gynecology, 2008
    Co-Authors: Christine K Mauck, Ron G Freziers, Terri Walsh, Karen Peacock, Jill L Schwartz, Marianne M Callahan
    Abstract:

    OBJECTIVE: To estimate the 6-month cumulative probability of pregnancy, short-term adverse effects, and acceptability of Cellulose Sulfate vaginal contraceptive gel. METHODS: Two hundred fertile heterosexual couples were enrolled in this single-center, phase II, 6-month noncomparative study conducted at the California Family Health Council in Los Angeles, California. Couples did not desire pregnancy, were at low risk for sexually transmitted diseases, and agreed to use 3.5 mL of Cellulose Sulfate gel intravaginally before each coital act as their primary means of contraception. Scheduled follow-up visits took place after one menstrual cycle and at study completion, which occurred after 6 months and six menstrual cycles had elapsed. In addition, participants were instructed to call the site at the onset of each menses to review their diary cards. RESULTS: The cumulative probabilities of pregnancy during 6 months and six cycles of typical use were 13.4% (95% confidence interval [Cl] 7.5-19.4%) and 13.9% (95% Cl 7.7-20.2%), respectively, and during 6 cycles of correct and consistent ("perfect") use: 3.9% (95% Cl 0.0-9.2%). Slightly over one fourth of the women and one man reported experiencing gel-related adverse events, two thirds of which were mild and only possibly related to the gel. Three quarters of women and men reported that they would buy Cellulose Sulfate gel for contraception. CONCLUSION: Cellulose Sulfate vaginal gel yields pregnancy rates comparable to nonoxynol-9 and few adverse events among couples at low risk for sexually transmitted diseases.

  • a randomized controlled safety trial of the diaphragm and Cellulose Sulfate microbicide gel in sexually active women in zimbabwe
    Contraception, 2007
    Co-Authors: Ariane Van Der Straten, Christine K Mauck, Sue Napierala, Helen Cheng, Teresa Depineres, Patricia Dhlakama, Marin Thompson, Tsungai Chipato, N Hammond, Nancy Padian
    Abstract:

    Abstract Background Cellulose Sulfate (CS) is an antimicrobial and contraceptive agent. We assessed its safety when used alone or with the diaphragm in Harare, Zimbabwe. Study Design This was a randomized controlled safety trial with three arms: diaphragm with 6% CS gel vs. diaphragm with KY gel vs. CS gel alone. Participants were instructed to use their study products before every sex act for a period of 6 months. Safety end points were assessed monthly by questionnaires and urinanalysis and bimonthly by clinical examinations, colposcopy, wet mounts and gram stains. Results One hundred nineteen monogamous women were enrolled (28% HIV+) and 105 (88%) completed the study. No urinary tract infections were diagnosed during the study; 81.4% women had symptoms and/or signs of genital irritation considered at least possibly related to the gel or device, and 41.5% had changes in vaginal flora. There were no statistically significant differences between treatment groups in safety end points. All six women with deep epithelial disruption were diaphragm users, and all such findings were on the external genitalia. Of those, 4 had herpetic ulcers which were unrelated to products use. Conclusions Cellulose Sulfate appeared safe when used for 6 months alone or with a diaphragm.

  • safety and acceptability of 6 Cellulose Sulfate vaginal gel applied four times per day for 14 days
    Contraception, 2007
    Co-Authors: A S Doh, Nkele Ngoh, Ron Roddy, Jaimjou Lai, Kim Linton, Christine K Mauck
    Abstract:

    Abstract Background Six percent Cellulose Sulfate (CS) is a vaginal gel that has been in development as a microbicide. Study Design This was a single-center, multi-dose, Phase I, placebo-controlled, randomized, fully masked study conducted in Yaounde, Cameroon, and involving sexually active women at low risk for sexually transmitted infections (STIs). Methods The study assessed the effect of CS and K-Y® Jelly applied vaginally four times per day, for 14 consecutive days, on genital epithelial disruption, candidiasis and bacterial vaginosis (BV). Acceptability of the products was also assessed. Twenty-seven women were enrolled in each treatment group. Results Two (7.4%) of the women in each group developed genital epithelial disruption. One (3.7%) of the women in each group developed candidiasis, and one (3.7%) of the K-Y users developed BV. One (3.7%) of the CS users said she would not buy her product for pregnancy prevention but would for STI prevention. All the remaining women indicated they would buy their product for both indications. Conclusion The results suggest that the safety and acceptability of 6% CS gel are comparable to that of K-Y Jelly.

  • fourteen day safety and acceptability study of 6 Cellulose Sulfate gel a randomized double blind phase i safety study
    Contraception, 2006
    Co-Authors: Jill L Schwartz, Christine K Mauck, Jaimjou Lai, Mitchell D Creinin, Vivian Brache, Susan A Ballagh, Debra H Weiner, Sharon L Hillier, Raina N Fichorova, Marianne M Callahan
    Abstract:

    Abstract Background Topical microbicides against the human immunodeficiency virus (HIV) 1 that are nonirritating to the female genital epithelium are urgently needed to slow the heterosexual spread of HIV infection. Products that are also effective contraceptives provide additional benefits. Cellulose Sulfate (CS) is a noncytotoxic antifertility agent that exhibits in vitro antimicrobial activity against sexually transmitted pathogens, including HIV. Methods We performed a multicenter, Phase I, placebo-controlled, randomized study to evaluate the genital toxicity of CS. Two cohorts of healthy women used 3.5 ml of 6% CS gel or 3.5 ml of K-Y Jelly, vaginally, bid, for 14 days. The first cohort was sexually abstinent, and the second cohort was sexually active. Results CS was associated with only a slightly higher odds ratio (OR) of symptoms of minor urogenital irritation compared to the inactive lubricant K-Y Jelly (OR=2.02, 95% confidence interval=0.90–4.53). In addition, there were minor shifts in some genital flora, but there was no evidence of greater inflammation as evidenced by few colposcopic findings, decreased influx of polymorphonuclear cells and minimal changes in proinflammatory cytokines. Moreover, both products appeared acceptable to most women. Product leakage was identified as more of a problem in sexually abstinent women, but less so in women using the product for sexual intercourse, as would be the case in actual practice. Conclusion CS was safe for twice-daily use for 14 days. CS is appropriate for future studies in effectiveness trials.

  • vaginal distribution of two volumes of the novel microbicide gel Cellulose Sulfate 2 5 and 3 5 ml
    Contraception, 2005
    Co-Authors: Kurt T Barnhart, Scott E Pretorius, Alka Shaunik, Kelly Timbers, Marlina D Nasution, Christine K Mauck
    Abstract:

    This was a blinded crossover study to determine the in vivo distribution of 2.5 and 3.5 mL of 6% Cellulose Sulfate gel. This potential vaginal microbicide was mixed with dilute gadolinium chelate and inserted into the vagina. Magnetic resonance imaging was performed at baseline and repeated after 5, 20, 35 and 50 min with subjects either resting or ambulating between data acquisitions. Use of 2.5 mL with no ambulation gave low linear spread (53.1% of vaginal length) and surface contact (61.7%) at 50 min. Using 3.5 mL of gel with ambulation improved linear spread (84.5%) and surface contact (85.9%) of the gel in the same time interval without significant leakage. Most linear spreading took place in the first 5 min after insertion, although lateral spreading continued to increase with time especially when ambulation took place. Leakage and gel was not a significant problem at either volume.