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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT01715103
Eligibility Criteria:
Inclusion Criteria:
* Free, informed and signed consent
* Person affiliated or beneficiary of a social security system or the Universal Health Coverage
* Female
* No menopausal, aged 18 to 45 years,
* Under oral contraceptive or implant
* Urine pregnancy test negative
* HBsAg and HCV serology negative
* Cervicovaginal smear normal older than one year,
* Normal vaginal smear dated within one year
For healthy women
\* HIV serology negative
For infected women
* HIV-1 infection checked by western-blot and/or the detection of HIV-RNA
* CD4+ T cells \>350/mm3 (several tests, since 6 months)
* Viral load \<40 copies/ml since 6 months
* Treated with antiretroviral drugs since 6 months
Exclusion Criteria:
* Significant history of vaginal pathology (malignancy, prolapse)
* Hysterectomy, conization
* History of abnormal Pap smear in the previous year (ASC-US, AG-US and LSIL and high grade according to Bethesda).
* Breakthrough bleeding;
* Clinical symptoms suggestive of genital infection within 10 days prior to the examination of the study,
* Antibiotic systemically within 10 days prior to the examination of the study,
* Immunosuppressive or immunomodulatory treatment in the last six months and corticosteroids (\> 20 mg / day for 5 days) in last 3 months
* Presence of other sexually transmitted infection detected in samples at pre-inclusion visit and ongoing at V1 visit (Mycoplasma, Chlamydia, gonorrhea, Trichomonas, Candida albicans and Syphilis)
* A person participating in another research including a period of exclusion still ongoing selection
* Population called vulnerable (minors, persons under guardianship, or deprived of liberty by a judicial decision.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01715103
Study Brief:
Protocol Section:
NCT01715103