Post Analytic Treatment Interruption Study
Recruiting · NCT02761200 · Observational (researchers observe without assigning treatment) · Lead sponsor: SEARCH Research Foundation
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 that would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
Where it is running
1 location listed.
- SEARCH - Bangkok, Bangkok, Thailand