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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT02572505
Eligibility Criteria:
Inclusion Criteria:
Woman:
* 18-40 years of age
* not pregnant
* BMI 18.5-30
* nonsmoker
* no use of IV drugs
* seronegative for HIV
* negative tests for hepatitis C and hepatitis B, human T-lymphotropic virus (HTLV I\&II), syphilis, Chlamydia trachomatis and Neisseria gonorrhea
* normal fertility examination
* normal PAP smear and HPV screen
Man:
* 18-50 years of age
* nonsmoker
* no use of IV drugs
* HIV-seropositive
* under the care of an infectious disease specialist
* without evidence of acquired immunodeficiency syndrome (AIDS)
* HIV viral load \<50,000 copies/mL and CD4 count \> 250 cells/mL for the preceding 6 month period
* taking anti-retroviral medication
* must be circumcised
* have 2 normal semen analyses
Couple:
* must be informed of safer choices (donor insemination, adoption, remaining childless)
* must attest to safe sexual practices.
Exclusion Criteria:
* either man or woman is incarcerated
* either man or woman is unable to provide informed consent
* woman is unable to take Truvada (tenofovir/emtricitabine) medication due to contraindications or adverse reaction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02572505
Study Brief:
Protocol Section:
NCT02572505