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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT03092505
Eligibility Criteria:
* INCLUSION CRITERIA:
1. At least 18 years of age
2. Female
3. Weight \>40 kilograms
4. A diagnosis of HIV infection as documented by any positive serological test (ELISA, HIV rapid test, or Western Blot)
5. Participants in Uganda must be eligible for ART by current clinical guidelines in Uganda
6. Willingness to begin ART
7. Will allow storage of biological sample
EXCLUSION CRITERIA:
1. Previous exposure to ART (participants with a brief exposure (\<3 months) that occurred greater thatn or equal to 6 months prior to screening will be eligible to enroll if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol)
2. On acyclovir, valacyclovir, valganciclovir, or ganciclovir treatment
3. Pregnancy or intent to become pregnant during the study period
4. Intrauterine device (IUD) use
5. Inability to follow study instructions, according to the investigator's judgment
6. Active, serious infections other than HIV infection that may interfere with study participation (eg, severe cerebral toxoplasmosis or cryptococcal meningitis) during the 2 weeks prior to enrollment
7. Malignancies requiring chemotherapy
8. Therapy with systemic corticosteroids, immunosuppressants or immunomodulating agents
9. Any condition that, in the investigator s opinion, may put the participant at undue risk or compromise the study's scientific objectives
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03092505
Study Brief:
Protocol Section:
NCT03092505