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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Undetectable plasma HIV-1 RNA and undetectable proviral DNA on suppressive antiretroviral therapy on at least two consecutive measures for at least 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 38 weeks
Awards & highlights
Study Summary
This trial is testing if people with HIV can be cured of the infection by stopping antiretroviral therapy (ART) and closely monitoring them for infection reactivation.
Who is the study for?
Adults over 18 with HIV, potentially cured after routine care, are eligible. They must have undetectable HIV RNA and proviral DNA for at least 6 months on therapy. Participants should use barrier contraception or abstain from sex during the trial. Pregnant or nursing women and those not using contraceptives are excluded.Check my eligibility
What is being tested?
The study tests if patients can be considered cured of HIV by stopping their antiretroviral therapy under medical supervision to see if the infection reactivates.See study design
What are the potential side effects?
Stopping HIV medication may lead to viral rebound, immune system weakening, and potential reactivation of dormant infections. Close monitoring is essential to manage any adverse effects promptly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My HIV is undetectable and I've been on treatment for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 38 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~38 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to virologic rebound
Secondary outcome measures
Time to HIV-1 RNA ≥ 100 copies/ml
Time to HIV-1 RNA ≥ 20 copies/ml
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment interruptionExperimental Treatment1 Intervention
Antiretroviral therapy will be discontinued under close laboratory monitoring and clinical supervision.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,766,850 Total Patients Enrolled
Andrew Badley, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or nursing.I cannot or will not use birth control methods during the trial.I am being treated for Hepatitis B to control the virus without affecting any HIV treatment.I have active Hepatitis C with liver damage.I am 18 years old or older.I have infections that could worsen with immune suppression and no treatment options.My HIV is undetectable and I've been on treatment for at least 6 months.I do not have severe heart, lung, or liver disease.I have a history of cancer that has not been treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment interruption
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this research?
"Based on what is available on clinicaltrials.gov, no more patients are being recruited for this trial which was initially posted in May 2015 and last edited at the end of April 2022. However, there are currently 240 other active trials recruiting individuals."
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