Clinical trial: A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants (NCT02039323)

Eligibility criteria:
Inclusion Criteria:

          -  Healthy pre-menopausal female subjects between the ages of 18-49, inclusive, with an
             intact uterus and cervix. (Healthy is defined as no irregular menstrual cycles or
             clinically relevant abnormalities identified by a detailed medical history, full
             physical examination, including blood pressure and pulse rate measurement, 12-lead ECG
             and clinical laboratory tests)

          -  All subjects must have an estimated calculated creatinine clearance (eCcr) of at least
             80 mL/min by the Cockcroft-Gault formula where: eCcr (female) in mL/min = [(140 - age
             in years) x (weight in kg) x 0.85] / (72x serum creatinine in mg/dL).

          -  All subjects must have a negative serum pregnancy test at screening and negative urine
             pregnancy tests on days of dose administration and should be using at least one of the
             following methods of contraception from the screening visit through 72 hours prior to
             first outpatient visit (at which time the women will be asked to remain abstinent
             until after their follow-up visit)

               -  Systemic hormonal contraceptive (oral, depot, transdermal or implant)

               -  Intrauterine device placed at least 1 month prior to study enrollment

               -  Bilateral tubal ligation (Sterilization)

               -  Vasectomized male partners

               -  Condom + Spermicide

               -  Unless engaged in sexual activity with female only sex partners or abstinent for
                  at least 3 months prior with no intention of becoming sexually active during the
                  study period. Any history of recent or present concomitant male sex partners will
                  be addressed and ruled out in the context of screening participants for
                  eligibility for the protocol

          -  Body Mass Index (BMI) of approximately 18 to 34 kg/m2; and a total body weight > 50 kg
             (110 lbs).

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject has been informed of all pertinent aspects of the trial.

          -  Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
             and other trial procedures.

          -  Subject must have documentation of a normal pap smear within 36 months of the
             screening visit, no procedures for abnormal cervical/vaginal pathology in the last six
             months, at least one prior gynecological visit as part of subject's routine medical
             history. If subjects have had a gynecological exam but no history of Pap smear, a Pap
             smear will be completed at screening and paid for by the study.

          -  Subject must be willing to abstain from sexual intercourse, douching, and all
             intravaginal objects and products for at least 72 hours prior to first study visit
             until study completion.

          -  Subject must be HIV-1 and Hepatitis B surface antigen negative as documented on
             screening labs.

          -  Subject must not be actively involved in the conception process.

          -  Subject must be able to swallow pills and have no allergies to any component of the
             study products.

        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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 1