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About
The purpose of this study is to determine the feasibility of a novel method to assess antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue biopsies.
Full description
Participants: Six premenopausal healthy volunteer women between 18-49 years of age with an intact uterus and cervix.
Procedures (methods): Subjects will be given a single dose of two oral antiretrovirals (maraviroc 600mg/tenofovir 600 mg). Subjects will be monitored and assessed for adverse events post-dose. Subjects will be sent home and asked to return in 24 hours. 24 hours post-dose, two vaginal and two cervical biopsies will be obtained. These biopsies will then be placed in an ex-vivo culture system and exposed to HIV. Viral RNA will be measured over two days to determine whether the tissues were protected from infection. A final visit for safety will be conducted 7-14 days post-enrollment.
Enrollment
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Volunteers
Inclusion criteria
Healthy pre-menopausal female subjects between the ages of 18-49, inclusive, with an intact uterus and cervix. (Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
All subjects must have an estimated calculated creatinine clearance (eCcr) of at least 80 mL/min by the Cockcroft-Gault formula where: eCcr (female) in mL/min = [(140 - age in years) x (weight in kg) x 0.85] / (72x serum creatinine in mg/dL).
All subjects must have a negative serum pregnancy test at screening and negative urine pregnancy tests on days of dose administration and should be using at least one of the following methods of contraception from the screening visit through 72 hours prior to first outpatient visit (at which time the women will be asked to remain abstinent until after their follow-up visit)
Body Mass Index (BMI) of approximately 18 to 34 kg/m2; and a total body weight > 50 kg (110 lbs).
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Subject must have documentation of a normal pap smear within 36 months of the screening visit, no procedures for abnormal cervical/vaginal pathology in the last six months, at least one prior gynecological visit as part of subject's routine medical history. If subjects have had a gynecological exam but no history of Pap smear, a Pap smear will be completed at screening and paid for by the study.
Subject must be willing to abstain from sexual intercourse, douching, and all intravaginal objects and products for at least 72 hours prior to first study visit until study completion.
Subject must be HIV-1 and Hepatitis B surface antigen negative as documented on screening labs.
Subject must not be actively involved in the conception process.
Subject must be able to swallow pills and have no allergies to any component of the study products.
Exclusion criteria
Primary purpose
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Interventional model
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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