Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel

Exclusion Criteria

• •Currently pregnant or at risk for pregnancy (may be using Paragard® IUD, effective barrier method, female sterilization or abstinence, or be sexually active with a vasectomized partner)
• •Currently breastfeeding or planning to breastfeed during the course of the study
• •Use of any hormonal contraceptives within 30 days of enrollment
• •Use of Depo-Provera within 120 days of enrollment History of abnormal Pap smear (by volunteer history) that has not been evaluated and treated, if indicated, according to standard guidelines
• •Current vaginal or urinary tract infection
• •Positive test for Neisseria gonorrhea or Chlamydia trachomatis at the time of screening
• •Positive wet mount for Trichomonas vaginalis at the time of screening or enrollment
• •Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
• •Current or past use of any anti-retroviral therapies including but not limited to systemic tenofovir (Viread®)
• •Current or recent drug or alcohol abuse
• •Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. tylenol)
• •HIV positive at the time of screening
• •Hepatitis B surface antigen (HBsAg) positive at the time of screening
• •Grade 1 or higher serum chemistry or complete blood count abnormality in accordance with DAIDS toxicity table values
• •Abnormal finding on laboratory or physical examination or a medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
• •Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during entire study duration