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Treatment Interruption for HIV (SCOPE-ATI Trial)
N/A
Recruiting
Led By Steven Deeks, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18
Antiretroviral therapy for at least 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through month 12
Awards & highlights
SCOPE-ATI Trial Summary
This trial will study how HIV and the host interact at the earliest stages, by having volunteers with HIV stop antiretroviral therapy (ART) and then have intensive studies done 2-3 times/week. Most will resume therapy within 3 weeks.
Who is the study for?
This trial is for adults over 18 with HIV who've been on antiretroviral therapy (ART) for at least a year, have undetectable virus levels, and a CD4+ count above 350. They must use two contraception methods if they can have children and agree to counseling to prevent HIV spread. It's not for those with severe kidney or liver disease, active hepatitis B or C, recent cancer, heart issues, or using certain other drugs.Check my eligibility
What is being tested?
The study examines what happens when people with HIV stop taking their ART medications temporarily. Participants will halt their treatment under close monitoring with frequent check-ups to see how the virus behaves and how the body responds without medication.See study design
What are the potential side effects?
Since this trial involves stopping ART medication rather than adding new treatments, side effects may include an increase in viral load and potential weakening of the immune system during the interruption period.
SCOPE-ATI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been on antiretroviral therapy for at least a year.
Select...
I can have children and agree to use two forms of birth control.
SCOPE-ATI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 0 through month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 through month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute retroviral syndrome
CD4+ T cell decline
Failure to re-suppress
+1 moreSCOPE-ATI Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment Interruption ArmExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,515 Total Patients Enrolled
Chan Zuckerberg BiohubOTHER
1 Previous Clinical Trials
600 Total Patients Enrolled
Steven Deeks, MDPrincipal InvestigatorUniversity of California, San Francisco
7 Previous Clinical Trials
1,084 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe liver problems or unstable liver disease.I have had cancer in the last 5 years.I am currently taking drugs that affect my immune system.I am 18 years old or older.My kidney function is severely reduced.I am on a specific HIV medication and cannot change it.I have been on antiretroviral therapy for at least a year.I can have children and agree to use two forms of birth control.I have serious heart or brain blood vessel problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Interruption Arm
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.
Is there a current recruitment process for participants in this experiment?
"Affirmative. Information on clinicaltrials.gov demonstrates that this medical experiment, posted on October 15th 2020 is actively searching for participants to join the 40-person cohort at 1 site."
Answered by AI
How many participants has this clinical trial been able to recruit?
"Confirmative. Per the information hosted on clinicaltrials.gov, this medical experiment is actively searching for patients as of April 27th 2022. This research was initiated October 15th 2020 and seeks to enrol 40 individuals from one location."
Answered by AI
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