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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT02614950
Eligibility Criteria:
Inclusion Criteria:
* Subject currently enrolled in SEARCH 010/RV254 Acute HIV Infection cohort.
* Male and females aged \> 18 years.
* Fiebig Stage I at entry to SEARCH 010/RV254 cohort.
* Taking ART \> 24 months.
* HIV-1 RNA \< 50 cps/ml for the past 12 months
* Integrated HIV in PBMCs below level of detection (1 copy/105 PBMCs) within the last 6 months
* Most recent (within 3 months) peripheral blood CD4 count \> 400 cells/mm3
* No HIV-related or AIDS Defining illness within the last 6 months (Appendix 1)
* Ability and willingness to provide written informed consent.
* Female-specific Criteria:
* Agrees not to become pregnant from the time of study enrollment until the last study visit. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to use a prescription birth control method or a barrier birth control method.
* Negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for any women unless she is post-menopause for 24 consecutive months or has undergone a surgical procedure that precludes pregnancy
Exclusion Criteria:
* Pregnancy or breast-feeding.
* Untreated Syphilis
* Hepatitis B surface antigen positive at any time in the past.
* Hepatitis C antibody positive at any time in the past.
* Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02614950
Study Brief:
Protocol Section:
NCT02614950