Clinical trial: Combined Oral Contraceptive (COC) Antiretroviral (ARV) Pharmacokinetics (PK) and Pharmacodynamics (PD) in Malawi (NCT00998725)

Eligibility criteria:
Inclusion Criteria:

          -  Can provide informed consent

          -  Women ages 21-35 with known HIV status

          -  If HIV negative must have had an HIV test within the last 3 months

          -  Intend to stay in Lilongwe region for the duration of the study

          -  Desire to prevent pregnancy for at least the next six months

          -  Desires to use LoFemenal for contraception

          -  Has no known history of infertility

          -  Has intact uterus and at least one ovary

          -  Has regular monthly menses defined by menses occurring every 21-35 days

          -  Has not used another form of systemic hormonal contraception within the last six
             months.

          -  Has no contraindications to the combined oral contraceptive LoFemenal which include;
             any thrombophlebitis or thromboembolic disorders; cerebral-vascular or coronary-artery
             disease (current or history); thrombogenic valvulopathies; thrombogenic rhythm
             disorders; major surgery with prolonged immobilization; diabetes with vascular
             involvement; headaches with focal neurological symptoms; uncontrolled hypertension;
             known or suspected carcinoma of the breast or personal history of breast cancer;
             carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia;
             undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice
             with prior pill use; hepatic adenomas or carcinomas or active lever disease, as long
             as liver function has not returned to normal; known or suspected pregnancy.

        Exclusion Criteria:

          -  Hemoglobin < 10 mg/dL.

          -  Body mass index < 18.6 kg/m^2.

          -  Using any drugs known to interfere with cytochrome P450 system (such as rifampicin,
             phenytoin, carbamezapine, among others)

          -  In the opinion of the PI or study staff the individual cannot complete the study

          -  Cannot be adherent to other medications.

        Additional inclusion criteria for the 3 HIV+ women on antiretroviral therapy:

          -  Must be on antiretroviral therapy which includes nevirapine for at least three
             consecutive months immediately prior to enrollment into the study

          -  Must report adherence to medication and medical visits

          -  Must be willing to use a barrier or backup method of contraception.
Female
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 35 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