Clinical trial: Vaginal Antibody Safety Trial: Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission of Herpes Simplex Virus (HSV) and Human Immunodeficiency Virus (HIV) (NCT02579083)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18 through 45 years (inclusive) at screening

          2. Able and willing to provide written informed consent to be screened for and enrolled
             in the study

          3. Able and willing to provide adequate locator information at screening

          4. HIV-uninfected based on testing performed by study staff at

          5. In general good health as determined by the site clinician

          6. Agree to abstain from any vaginal insertions, including products, douches, devices
             such as sex toys, or penile or oral intercourse from 5 days prior to Visit 2
             (Enrollment Visit) until the final Study Visit (one week after last dose of study
             film). Only tampons during menses and clinically indicated speculum exams are allowed.

          7. Agree to use condoms provided by the study staff from one week after last use of study
             film until three weeks after last use of study film

          8. Willingness to undergo all study-related assessments and follow all study-related
             procedures

          9. Be currently using an effective method of contraception at enrollment (used
             continuously and with good compliance for the past 60 days as determined by
             participant self-report) with plans to continue use throughout the study period.
             Acceptable methods include any hormonal method (except vaginal ring); intrauterine
             device (IUD) inserted at least 90 days prior to enrollment; female sterilization;
             abstinent from sexual activity with male partner for the past 60 days; sexual activity
             with vasectomized partner; engages in sex exclusively with women.

         10. For participants 21 and older, a Pap result in the 36 calendar months prior to the
             Enrollment Visit 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 satisfactory evaluation with no treatment required of
             non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology
             (ASCCP) guidelines or per local standard of care, within the last 36 calendar months
             prior to enrollment. Note: For participants aged 18-21, a Grade-0 or adequately
             evaluated abnormal Pap smear is not required as the American Society for Colposcopy
             and Cervical Pathology recommends initiating screening at age 21.

         11. At screening and enrollment, agrees not to participate in other research studies
             involving drugs, medical devices, or vaginal products while enrolled in this trial -

        Exclusion Criteria:

          1. Menopausal at screening (as defined as amenorrhea or irregular periods for one year or
             more without an alternative etiology)

          2. Hysterectomy

          3. Known adverse reaction to any of the study products (ever)

          4. Known adverse reaction to latex (ever)

          5. Non-therapeutic injection drug use in the 12 months prior to screening

          6. Surgical procedure involving the pelvis in the 90 days prior to screening (includes
             dilation and curettage or evacuation, and cryosurgery; does not include cervical
             biopsy for evaluation of an abnormal pap smear or IUD placement)

          7. Participation in a drug, spermicide and/or microbicide study in the 30 days prior to
             screening or anticipated participation in an investigational drug study in the next 8
             weeks

          8. Pregnancy within 90 days prior to screening

          9. Lactating

         10. Use of a diaphragm, NuvaRing®, or spermicide for contraception

         11. As determined by the PI, a degree of menstrual cycle irregularity that would make it
             difficult to schedule follow up visits without interruption by menses

         12. Active sexually transmitted infection or documented treatment of sexually transmitted
             infections in the last 6 months, including, but not limited to: chlamydia, gonorrhea,
             syphilis, trichomonas, cervicitis or pelvic inflammatory disease, or currently active
             HSV lesions or other sores. (Participants seropositive for or with a history of HSV
             without current active lesions will not be excluded.)

         13. Women who by history engage in condom-less intercourse with HIV-infected partners, or
             who exchange sex for money, shelter, or gifts, or who in the opinion of the
             investigators, may be at risk for HIV acquisition during the duration of the study

         14. More than one sex partner within the past 3 months

         15. Current sexual partner known by participant to be HIV seropositive

         16. Current or planned use of pre-exposure prophylaxis against HIV infection

         17. Currently active genital HSV lesions, or other genital tract epithelial disruption or
             inflammation

         18. Current or episodic use of anti-herpes suppressive therapy

         19. Urinary tract infection, symptomatic candidiasis, or symptomatic bacterial vaginosis
             within 14 days of enrollment, or currently residual symptoms thereof Note: women with
             these infections at screening can be enrolled after treatment and resolution of the
             infection.

         20. Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment

         21. Use of systemic immunomodulatory medications within 4 weeks of enrollment

         22. Menses or other vaginal bleeding at the time of enrollment* or expecting menses in the
             10 days after enrollment (Segment A participants) or 16 days after enrollment (for
             Segment B participants)

             *Note: for women with monthly cycles, every attempt will be made to enroll these
             participants in the first half of their menstrual cycle. Women who have vaginal
             bleeding at the scheduled Enrollment Visit may return at a different date to be
             re-examined and possibly enrolled provided they are still within the screening window
             and meet all criteria.

         23. Lack of stable living conditions to allow reliable room temperature storage of study
             product (Segment B participants only)

         24. At enrollment has any of the following laboratory abnormalities per the Division of
             AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events,
             Version 2.0, Nov 2014:

               -  Grade 1 or higher AST (aspartate aminotransferase) or ALT (alanine
                  aminotransferase)

               -  Grade 1 or higher creatinine

               -  Grade 2 or higher hemoglobin

               -  Grade 1 or higher platelets Note: otherwise eligible participants with an
                  exclusionary test may be re-tested once during the screening process.

         25. As determined by the Principal Investigator (PI), any subject who has any significant
             uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic,
             gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or
             infectious disease, anticoagulation with warfarin or heparin; or any other condition
             that, in the opinion of the Investigator, would preclude provision of consent, make
             participation in the study unsafe, complicate interpretation of study outcome data, or
             otherwise interfere with achieving the study objectives.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? Entailment