male tolerance study of dapivirine gel following multiple topical penile exposures

Conditions: Topical Penile Exposures

Summary: the purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at screening, verified per site standard operating procedure (sop) * able and willing to provide written informed consent to be screened for and take part in the study * at screening, able and willing to provide adequate locator information, as defined per site sop * able and willing to communicate in written and spoken english * hiv-uninfected at screening per algorithm in appendix ii * in general good health, according to the clinical judgment of the investigator of record (ior) or designee * willing to abstain from vaginal, oral and anal intercourse (including receptive anal intercourse), even with a condom; masturbation, and other activities that may cause irritation or injury to the penis during study participation * willing to abstain from using any genitally-applied preparations (except use of usual cleansing products for genital hygiene) other than the study product during study participation * willing to abstain from non-urgent surgical procedures of the penis/gu area for the duration of study participation (e.g. circumcision) * at screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed) exclusion criteria: * participant report of any of the following: * known adverse reaction to any of the study products or components of the study products (ever) * post-exposure prophylaxis (pep) for hiv exposure within 6 months prior to enrollment * penile procedures (e.g. biopsy, circumcision) within 42 days or less prior to enrollment * participation in any other research study involving drugs, medical devices, or genital products within 30 days or less prior to enrollment * within the three months prior to enrollment, history of a non-gonococcal urethritis and/or sexually transmitted infection (sti), including outbreak of genital herpes or condylomata * for uncircumcised men, the treatment of candidal balanoposthitis/ balanitis within 30 days prior to enrollment * history of recurrent dermatosis (e.g. eczema) * non-therapeutic injection drug use in the 12 months prior to screening * currently using an immunosuppressant (with the exception of local nongenital use of low potency products e.g. inhaled corticosteroid for asthma) * has any of the following laboratory abnormalities at screening: * hemoglobin \< 10.0 g/dl * platelet count \< 100,000/mm3 * white blood cell count \< 2,000 cells/mm3 * alanine transaminase (alt) and/or aspartate aminotransferase (ast) \> 2.5x the site laboratory upper limit of normal (uln) * serum creatinine \> 1.3x the site laboratory uln * calculated creatinine clearance less than 80 ml/min by the cockcroft-gault formula where creatinine clearance in ml/min = (140-age in years) x (weight in kg) x 0.85/72 x serum creatinine in mg/dl note: otherwise eligible participants with any of the above exclusionary laboratory results may be re-tested. if a participant is re-tested and a non exclusionary result is documented within 30 days of providing informed consent for screening, the participant may be enrolled. * at screening or enrollment, diagnosed with sti or reproductive tract infection (rti) requiring treatment, per current centers for disease control and prevention (cdc) guidelines * at screening or enrollment, has a clinically apparent grade 1 or higher genital exam finding (observed by study staff) * at screening or enrollment, has grade 1 or higher genital or urinary symptoms * at screening or enrollment, diagnosed with phimosis or hypospadias * at screening or enrollment, penile, scrotal piercing or penile tattoos observed during genital examination * has any other condition that, in the opinion of the ior/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: male tolerance hiv-1 microbicide dapivirine