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:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT01656018
Eligibility Criteria:
Inclusion Criteria:
* Human immunodeficiency virus type 1 (HIV-1) seronegative at screening and enrollment
* Not pregnant or breastfeeding females
* Agrees to protocol-defined method of contraception
* Abstinence from insertion of anything in rectum (eg, medication, enema, penis, or sex toy) for 72 hours before and 72 hours after each rectal biopsy visit
* Abstinence from insertion of anything in vagina (eg, tampon, medication, douche, penis, or sex toy) for 72 hours before and 72 hours after each cervical and vaginal biopsy visit
Exclusion Criteria:
* Post-exposure prophylaxis for HIV exposure within 6 months prior to screening and known HIV-infected partners
* Use of systemic immunomodulatory medications within the 4 weeks prior to the enrollment
* Use of vaginally or rectally administered medications or products (including condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the enrollment
* Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies
* History of recurrent urticaria
* History of or electrocardiogram demonstrating prolonged QT interval
* History of significant gastrointestinal bleeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01656018
Study Brief:
Protocol Section:
NCT01656018