methylcellulose and Sexually-Transmitted-Diseases

To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel.. A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand.. Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews.. One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability.. Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Topics: Administration, Intravaginal; Anti-Infective Agents; Drug Delivery Systems; Female; Gels; Humans; Methylcellulose; Patient Acceptance of Health Care; Placebos; Safety; Sexual Behavior; Sexually Transmitted Diseases; Thailand; Vaginal Diseases

The human immunodeficiency virus (HIV-1) pandemic has been driven primarily by the sexual transmission of the virus, and facilitated by prior infections with other sexually transmitted disease (STD) pathogens. Although treatment of these STDs has been proposed as a means to decrease the rate of HIV-1 sexual transmission, preventive measures effective against both HIV-1 and other STD pathogens are expected to have a larger impact. These measures include topically applied mechanical and chemical (i.e. microbicidal) barriers. Microbicides of preference should have a broad specificity against diverse STD pathogens and a well established safety record, considering their repeated use over decades. Here, we report that cellulose acetate phthalate (CAP), an "inactive" pharmaceutical excipient, commonly used in the production of enteric tablets and capsules: (1) has antiviral activity against HIV-1 and several herpesviruses (HSV); and (2) when appropriately formulated, in micronized form, inactivates HIV-1, HSV-1, HSV-2, cytomegalovirus, Neisseria gonorrhoeae, Trichomonas vaginalis, Haemophilus ducreyi and Chlamydia trachomatis but does not affect Lactobacilli, components of the natural vaginal flora contributing to resistance against STDs. Thus, the CAP formulations meet the criteria for preferred microbicides and warrant further evaluation in vivo in humans.

Topics: Animals; Anti-Bacterial Agents; Anti-Infective Agents; Cell Line; Cellulose; Chlamydia trachomatis; Drug Evaluation, Preclinical; Excipients; Haemophilus ducreyi; Herpesvirus 1, Human; Herpesvirus 2, Human; HIV Infections; HIV-1; Humans; Lactobacillus; Methylcellulose; Microbial Sensitivity Tests; Neisseria gonorrhoeae; Sexually Transmitted Diseases; Trichomonas vaginalis