Pharmacokinetic and Pharmacodynamic Study of Tenofovir 1% Gel

Exclusion Criteria

• •History of hysterectomy;
• •Currently pregnant or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome;
• •Use of Depo-Provera in the last 120 days;
• •Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study;
• •History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to both silver nitrate and Monsel's solution;
• •In the last six months, diagnosed with or treated for any STI or pelvic inflammatory disease. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility;
• •Symptomatic vulvovaginal candidiasis, Nugent score greater than equal to 7 at screening or symptomatic bacterial vaginosis (BV) at Visit 2, or symptomatic urinary tract infection (UTI);
• •Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis;
• •Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection;
• •Positive test for HIV;
• •Positive test for Hepatitis B surface antigen (HBsAg);
• •Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy;
• •Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.);
• •Known current drug or alcohol abuse which could impact study compliance;
• •Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events;
• •Systemic use in the last two weeks or anticipated use during the study of drugs on a daily basis that may reduce renal function (e.g., ibuprofen) or liver function (e.g., Tylenol®), or that may affect anti-HSV activity (e.g., acyclovir or valacyclovir) of any of the following: corticosteroids, antibiotics, antifungals, antivirals (e.g. acyclovir or valacylovir) or antiretrovirals (e.g. Viread®). Note: Participants should avoid nonsteroidal anti-inflammatory drugs (NSAIDs) except for treatment of dysmenorrhea during menses. Participants may use Tylenol® on an as-needed but not daily basis during the study
• •Participation in any other investigational trial (device, drug, or vaginal trial)within the last 30 days for this study or planned participation in any other investigational trial during the study;
• •History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days; and
• •Abnormal finding on laboratory or physical examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data.