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Recruiting NCT02761200

Post Analytic Treatment Interruption Study

Trial Parameters

Condition HIV
Sponsor SEARCH Research Foundation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-03
Completion 2031-03

Brief Summary

This exploratory study is designed to ensure the safety of HIV-infected volunteers who complete research protocols that include an analytic treatment interruption (ATI). This is a prospective cohort study of volunteers who were diagnosed with HIV during early acute HIV infection, treated with antiretroviral therapy (ART) and subsequently enrolled in a clinical study that included ATI. After completion of study participation that involves ATI, participants will be recruited into this study for continued clinical and laboratory monitoring.

Eligibility Criteria

Inclusion Criteria: * Man or woman aged ≥18 years. * Enrolled in RV254 study. * Completed clinical research protocol that included ATI within one month of enrollment in this protocol. * Able and willing to provide written informed consent or, in the case of illiteracy, witnessed verbal informed consent with documentation of a thumbprint in lieu of a signature. * Able to participate in study visits for up to 144 weeks. * Willing to have photo or fingerprint taken for identification purposes. * Female-specific criteria: Agrees not to become pregnant while not receiving ART. If a woman is sexually active and has no history of hysterectomy or tubal ligation or menopause, she must agree to engage in abstinence, use a prescription birth control method or use a barrier birth control method while not receiving ART. Exclusion Criteria: * History of a medical or psychiatric condition that, in the opinion of investigator, would jeopardize the safety or rights of the subject, such as a condition t

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