Safety and Virologic Outcomes After HIV Remission Trials in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
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.
• 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.