Clinical trial: Coital Pharmacokinetics/Pharmacodynamics (PK/PD) of Tenofovir Gel (NCT01687205)

Eligibility criteria:
Inclusion Criteria:

        Men and women must meet the following criteria to be eligible for inclusion in the study:

          1. Able and willing to provide the following:

               -  Written informed consent to be screened for and take part in the study

               -  Adequate locator information, as defined in site SOPs

          2. Per participant report, at low risk for HIV/STI. Low risk is defined as:

               -  No STIs in the 6 months prior to Screening

               -  No non-therapeutic intravenous drug use in the 18 months prior to Screening

               -  In a mutually monogamous relationship with a partner of the opposite sex for 6
                  months prior to Screening and the intent to stay in this relationship for the
                  next 4 months

          3. At Screening and Enrollment, both partners independently report not using barrier
             contraception and/or barrier protection as part of normal coital routine and report
             the intent to continue said sexual practice for the duration of study participation

          4. HIV-uninfected based upon testing performed by study staff at Screening (per protocol
             algorithm)

          5. Agrees not to participate in other research studies involving drugs, medical devices,
             or genital and rectal products, or large blood draw studies during study participation

          6. Women must also meet the following criteria:

               -  Age 21 through 46 years (inclusive) at Screening, verified per site SOPs

               -  Pap result in the 12 calendar months prior to Screening consistent with Grade 0
                  according to the Female Genital Grading Table for Use in Microbicide Studies
                  Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events,
                  Version 1.0, December 2004 (Clarification dated August 2009), or satisfactory
                  evaluation with no treatment required of non-Grade 0 Pap result per American
                  Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12
                  calendar months prior to the Screening Visit

             Note: Women with a documented normal result within the 12 months prior to screening
             need not have a Pap smear during the screening period. Women with abnormal Pap smears
             can be enrolled upon completion of the initial phase of evaluation if no current
             treatment is indicated (based on local standard of care for management of abnormal
             cervical cytology). Need for a repeat Pap within 6 months does not preclude enrollment
             prior to that result becoming available.

               -  Must be currently using effective non-barrier contraception, other than a
                  contraceptive vaginal ring, for at least three months prior to Screening (i.e.,
                  oral contraceptive, patch, injectable hormones, subdermal implants, intrauterine
                  device, female or male sterilization) and intending to use this method for the
                  course of the study

               -  Per participant report, regular menstrual cycles with at least 21 days between
                  menses (does not apply to participants who report using a progestin-only method
                  of contraception at screening, e.g., Depo-Provera)

             Note: This criterion is not applicable to participants using continuous combination
             oral contraceptive pills, as the absence of regular menstrual cycles is an expected,
             normal consequence in this context.

               -  Anatomy sufficient for performing pelvic examinations and for collecting vaginal
                  and cervical specimens

               -  Female participants must also agree to abstain from intercourse (oral, anal, or
                  penile-vaginal) and other vaginal practices (e.g., masturbation, douching, tampon
                  use, application of lubricants/spermicides or other related practices) 72 hours
                  prior to each follow-up visit.

          7. Men must also meet the following criteria:

               -  Age 21 or older at Screening, verified per site SOPs

               -  Agree to abstain from intercourse (oral, anal, or penile-vaginal) and other
                  penile practices (e.g., masturbation, application of lubricants/spermicides or
                  other related practices) 72 hours prior to each follow-up visit.

        Exclusion Criteria:

        Men and women who meet any of the following criteria will be excluded from the study.

          1. Participant report of any of the following:

               -  Known allergy to the study product (ever)

               -  Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to
                  Screening

               -  Participation in any other research study involving drugs, medical devices, or
                  genital products 30 days or less prior to Enrollment

               -  Plans to relocate away from the study site in the next 4 months

               -  History of domestic violence with current partner (ever)

               -  Systemic or topical antimicrobials within the last 7 days prior to Enrollment

               -  Currently using or planning to use pharmacologic immune modulator(s)

          2. At Screening or Enrollment, symptomatic urinary tract infection (UTI)

             Note: Otherwise eligible participants diagnosed with UTI during screening are offered
             treatment and may be enrolled after completing treatment and all symptoms have
             resolved as long as treatment is completed and all symptoms have resolved within 30
             days of obtaining informed consent for Screening/Enrollment.

          3. At Screening, has a positive hepatitis B surface antigen (HBsAg) test result

          4. At Screening or Enrollment, has an STI or reproductive tract infection (RTI) requiring
             treatment per current CDC guidelines

          5. Genital signs and/or symptoms of Grade 2 or higher

             Note: For female participants, cervical bleeding associated with speculum insertion
             and/or specimen collection judged to be within the range of normal according to the
             clinical judgment of the IoR/designee is considered expected non-menstrual bleeding
             and is not exclusionary.

             Note: Otherwise eligible participants with exclusionary genital findings may be
             enrolled after the findings have improved to a non-exclusionary severity grading or
             resolved as long as treatment is completed and all symptoms have resolved within 30
             days of obtaining informed consent for Screening/Enrollment.

          6. 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

          7. Women who meet any of the following criteria will be excluded from the study:

               -  Participant report (or clinical finding) of the following:

                    -  Last pregnancy outcome 90 days or less prior to Enrollment

                    -  Currently pregnant

             Note: Self-reported pregnancy is adequate for exclusion from the study. A documented
             negative pregnancy test performed by study staff is required for inclusion.

               -  Currently breastfeeding

               -  Intends to become pregnant in the next 4 months

               -  Gynecologic or genital procedure (e.g., tubal ligation, dilation and curettage)
                  within the prior 30 days to Enrollment

             Note: This does not include biopsy for the evaluation of an abnormal pap result or
             endometrial biopsy that occurred more than 7 days prior to Enrollment.

               -  Any of the following laboratory abnormalities at Screening:

                    -  Hemoglobin less than 10.0 g/dl

                    -  Platelet count less than 100,000/mm3

             Note: Otherwise eligible participants with an exclusionary test may be re-tested
             during the screening process

               -  Use of a vaginal douche or other intravaginal products (excluding tampon use) in
                  the 30 days prior to Enrollment

               -  Currently menopausal or perimenopausal

          8. Men who meet any of the following criteria will be excluded from the study:

               -  Participant report of penile procedures (e.g. biopsy, circumcision) within 42
                  days prior to Enrollment

               -  For uncircumcised men, per participant report, treatment of candidal
                  balanoposthitis/ balanitis within 30 days prior to Enrollment
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 46 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0