SCOPE Analytic Treatment Interruption Protocol for HIV
This study aims to understand how HIV interacts with your body when you temporarily stop taking your HIV medications (antiretroviral therapy or ART). You would pause your ART, and researchers would closely monitor your health and virus levels, often two to three times a week. Most participants will restart ART within three weeks, even if their virus levels haven't gone up. The main goals are to see if you develop acute retroviral syndrome, if your virus levels go back down after restarting ART, and if your CD4+ T-cell count (a measure of immune health) declines. To join, you must be at least 18 years old, have documented HIV, have been on ART for at least 12 months with undetectable virus levels, and have a CD4+ T-cell count above 350.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. It involves a treatment interruption arm where participants will pause their ART.
- What's involved
- You will interrupt your ART and have intensive studies performed two to three times per week. Most will resume therapy within three weeks, or once the virus is detectable.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health will be monitored for acute retroviral syndrome for up to 6 months, failure to re-suppress for up to 12 months, and CD4+ T cell decline for up to 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
SCOPE Analytic Treatment Interruption Protocol
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Steven Deeks, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Acute retroviral syndromeWeek 0 through Month 6
The proportion of participants developing acute retroviral syndrome
- Failure to re-suppressWeek 0 through Month 12
The proportion of participants who fail to re-suppress to plasma HIV RNA levels \<50 copies/mL after re-initiating ART
- CD4+ T cell declineWeek 0 through Month 6
The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL
- Time to reboundWeek 0 through Month 6
The time between the treatment interruption and plasma HIV RNA \>200 copies/mL