Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01749566
Eligibility Criteria:
Inclusion Criteria:
* Female sex, defined by sex at birth
* Age greater than or equal to 18 years
* Negative HIV serology at screening
* Normal menses (within 22-35 day intervals) for at least 3 cycles
* Intact uterus and cervix
* Normal chemistry and CBC panels at screening, including
* Absolute neutrophil count (ANC) greater than 750/mm3
* Hemoglobin greater than 10.0 g/dL
* Platelet count greater than 100,000/mm3
* Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase less than 3 x upper limit of normal
* Total bilirubin less than 2.5 x upper limit of normal
* CrCl greater than or equal to 60 mL/min as estimated by the Cockcroft- Gault equation
* Negative hepatitis B surface antigen
* Willing to use condoms for the duration of the study and abstain from sexual intercourse for 48 hours before each genital tract sampling
* Able and willing to provide informed consent
Exclusion Criteria:
* Pregnancy (by clinical history or positive urine pregnancy test at screening)
* Breastfeeding
* Alcohol or substance use that, in the opinion of the study investigator, would interfere with the conduct of the study
* History of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery
* Use of systemic hormonal contraception
* Orthostasis at screening, defined as systolic blood pressure decrease of at least 20 mm Hg or a diastolic blood pressure decrease of at least 10 mm Hg within three minutes of standing.
* Known history of heart or liver disease
* Known history of any medical condition that would interfere with conduct of the study, in the opinion of the study investigator
* Symptoms of active vaginal infection at the time of screening, including new ulcerative genital lesions or purulent and/or foul-smelling vaginal discharge
* Visible ulcerative genital lesions or purulent vaginal discharge during speculum pelvic examination performed at the time of screening
* Concomitant use of medications that interact with maraviroc or known allergy to maraviroc
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01749566
Study Brief:
Protocol Section:
NCT01749566