Clinical trial: Study of UC-781 Vaginal Microbicide (NCT00132444)

Eligibility criteria:
Inclusion Criteria:

        For All Females:

          -  Ages 18-45 years of age

          -  Able to provide written informed consent

          -  Normal Pap smear at screening or documentation of such within six months prior

          -  Regular monthly menses or amenorrhea due to hormonal contraceptive use

          -  Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol

          -  Able/willing to complete Study Diary

          -  Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit

          -  Agree to apply assigned study gel as required per protocol

          -  Agree to abstain from the following activities from at least 48 hours prior to
             enrollment through the Day 14 visit:

               -  Insertion of fingers/objects into the vagina

               -  Receiving oral sex

               -  Receiving anal sex

               -  Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring

               -  Using vaginal products other than the study gels

               -  Participating in other vaginal microbicide or contraceptive studies

        Additional Inclusion Criteria for Stage 1:

          -  HIV-uninfected

          -  In a monogamous sexually active relationship with one male partner throughout the
             study

          -  Report having vaginal intercourse only with that partner at least two times per week

          -  Agree to use study-provided male condoms for each act of vaginal intercourse while
             taking part in the study

          -  Agree to inform male partner about participation

        Additional Inclusion Criteria for Stage 2:

          -  HIV-infected

          -  Sexually abstinent or agree to abstain from sexual intercourse while taking part in
             the study

          -  Under regular medical care for HIV management

          -  CD4+ lymphocyte count > 200/mm3 for the last 6 months

          -  HIV viral load > 4.0 log10 copies/ml at screening

          -  Documentation of prior HIV genotype with one or more mutations conferring resistance
             to a non-nucleoside reverse transcriptase inhibitor (NNRTI)

          -  Not currently on antiretrovirals

          -  Willing to provide study staff with access to medical records related to their HIV
             infection

        Inclusion Criteria for Male Partners:

          -  Ages 18 years or older

          -  Able to give written informed consent

          -  Male sexual partners of HIV-uninfected women taking part in Stage 1 of the study

        Exclusion Criteria:

        Exclusion Criteria for All Females:

          -  Are post-menopausal

          -  Have had a hysterectomy

          -  Clinically significant chronic medical condition (other than HIV) that is considered
             progressive.

          -  History of malignancy, with the exception of basal cell or squamous cell skin cancer

          -  Pregnant or planning to become pregnant in the next three months

          -  Currently breastfeeding

          -  History of sensitivity or allergy to latex or any compound used in this study

          -  Have received antibiotics in the 14 days prior to enrollment

          -  Have used a spermicide or spermicidally lubricated condom within 7 days prior to
             enrollment

          -  Have been using a hormonal contraceptive method for less than 3 months prior to
             enrollment

          -  Have participated in other microbicide or contraceptive studies in the past three
             months

          -  Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for
             Grading the Severity of Adult Adverse Events at screening

          -  Have a positive bacterial urine culture

          -  Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal,
             cervical and/or perineal ulcer or lesions or abnormal Pap smear)

          -  In the three months prior to enrollment have had any of the following:

               -  An abnormal Pap smear

               -  A pregnancy

               -  An abortion

               -  An intrauterine device (IUD)

               -  Breakthrough menstrual bleeding

               -  Vaginal bleeding during or following vaginal intercourse

               -  Gynecologic surgery

               -  Signs consistent with a sexually transmitted disease (STD)

               -  Signs of genital trauma

               -  Signs of genital tract infection other than asymptomatic bacterial vaginosis (BV)

          -  In the six months prior to enrollment have had any of the following:

               -  History of treatment for or a diagnosis with a new STD

               -  Exchanged sex for money, drugs or gifts

               -  Protected (with condoms) penile-vaginal or penile-anal sexual contact with more
                  than 4 partners

               -  Unprotected (without condoms) penile-vaginal or penile-anal sexual contact with
                  more than 1 partner

               -  A male sexual partner who was diagnosed or treated for an STD (other than HIV)

               -  A male sexual partner who has injected drugs

          -  Are currently using, or in the last year have used intravenous drugs (except for
             therapeutic use), crack or other recreational drugs

          -  Are currently abusing, or in the last year have abused alcohol.

          -  Any other condition that, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives

        Additional Exclusion Criteria for Stage 1:

          -  Unprotected (without condoms) or protected (with condoms) penile-vaginal or
             penile-anal sexual contact with an HIV-infected partner in the past 6 months

          -  Unwilling to use study-provided male condoms while on study

        Additional Exclusion Criteria for Stage 2:

          -  NNRTI mutations in plasma and/or genital secretions at screening
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? Contradiction