Post Analytic Treatment Interruption Study (NCT02761200) | Clinical Trial Compass
RecruitingNot Applicable
Post Analytic Treatment Interruption Study
Thailand100 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Antiretroviral therapy (ART) resumption for any reason