Clinical trial: A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women (NCT00213044)

Eligibility criteria:
Inclusion Criteria:

          -  Age 18-50 years

          -  Plan to stay in the Chiang Rai area for at least four months

          -  HIV-infected, confirmed by Elisa and Western Blot tests

          -  Either has 1) no current sex partner and is planning to be abstinent for the study
             duration, or 2) has only one, HIV-infected sexual partner1 who is 18 years or older
             and is willing to give informed consent for confirmatory HIV testing and for the
             participant=s enrollment in the study. Women who have a steady partner/husband who she
             will not see during the study period or with whom she is not sexually active will not
             be required to bring their partner to the clinic for HIV testing and informed consent.

          -  Willing and able to give informed consent

          -  Willing and able to comply with the study protocol, including being tested for HIV and
             undergoing repeated pelvic and colposcopic examinations

          -  Willing to have male partner asked for informed consent because he will be exposed to
             study product

          -  Regular menstrual cycles (defined as occurring every 3-5 weeks, lasting 3-5 days) for
             the prior 3 months; if have amenorrhea or if using depo-provera, participant must have
             no reported history of vaginal bleeding for the previous 3 months

          -  CD4 count < 5002

          -  Not currently taking antiretroviral medications3

          -  Documented Class I or Class II ("atypical cells seen, usually caused by inflammation")
             pap smear at screening for study participation

          -  In good health as determined by medical history, physical examination and results of
             any laboratory screening test, and the discretion of the clinical staff

          -  Able to achieve a score of 80% or better on true-false test of key study concepts. If
             women score less than 80% the first time they take the test, they may repeat the test
             at least one day later

        Exclusion Criteria:

          -  CD4 count <50

          -  Pregnancy or desire to become pregnant in the next 3-4 months

          -  Delivery, miscarriage, or abortion within six weeks prior to study enrollment

          -  History of surgery on external genitalia, vagina or cervix in the month prior to study
             enrollment

          -  Existence of a clinically detectable genital abnormality, specifically warts or a
             congenital abnormality

          -  History of nonmenstrual vaginal bleeding with intercourse in past one month

          -  Current use of tampons, diaphragms, sponges, douching, or other intravaginal products.
             Women who are willing to abstain from using these products during the study will be
             included in the study.

          -  Concurrent participation in another trial of a vaginal product

          -  History of sensitivity or allergy to latex products (including gloves)

          -  Presence of epithelial disruption of the labia or genital mucosa visible to the naked
             eye at enrollment1

          -  Positive test for gonorrhea, chlamydial infection, trichomoniasis, or evidence of
             untreated syphilis (see section 5.19). Participants with positive tests must be
             treated and have a negative test of cure to be eligible for enrollment.1

          -  Positive tests for candidiasis or bacterial vaginosis (BV) and symptoms of vaginitis.
             Women may be enrolled after treatment if they are asymptomatic or have negative tests.
             Asymptomatic participants with positive tests for candidiasis or BV may be enrolled.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 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