A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants

Exclusion Criteria

• •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including documented drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• •Subjects with a history of hysterectomy, or other clinically significant surgery of the female genital tract.
• •Subjects who are pregnant, possibly pregnant or lactating
• •Subjects with a presence of vaginal discharge or genital bleeding at screening
• •History of febrile illness within five days prior to medication dosing.
• •Any condition possibly affecting drug absorption (eg, gastrectomy).
• •A positive urine drug screen.
• •A positive result for HIV.
• •Active Hepatitis B infection as determined by positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) tests (in the absence of HBsAb).
• •Active Hepatitis C (HCV) infection as defined by positive HCV Ab (determined by multi-antigen EIA) and detectable Hepatitis C RNA.
• •A positive test for syphilis, gonorrhea, Chlamydia, or trichomonas at screening.
• •Any laboratory chemistry or hematology result Grade 2 or greater according to the Division of Allergy and Infectious Disease (DAIDS) Laboratory Grading Tables
• •Treatment with an investigational drug within 4 months preceding the first dose of trial medication.
• •History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.
• •Use of prescription or nonprescription drugs, vitamins, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication and unable to avoid use during the inpatient pharmacokinetic visit. As an exception, systemic hormonal methods of contraception can be continued.
• •History of sensitivity to heparin or heparin-induced thrombocytopenia.
• •Allergy to lidocaine or Monsel's solution.
• •Allergy to latex.
• •Abnormal pap smear in the past 12 months
• •Any degree of ectopy or abnormality evident during the pelvic exam at screening.
• •Any condition which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately.
• •Unwilling or unable to comply with the following dietary and concomitant drug restrictions in regard to study drug administration as outlined in the study procedures and prohibited medications sections.
• •Subjects will not be allowed to eat or drink grapefruit containing products from 7 days prior to the first dose of trial medication until after collection of biopsy sample.
• •Must refrain from taking any prescription, non-prescription, herbal, vitamin or dietary supplement within at least 7 days of the study visit through completion of the study without discussing with the study staff.