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.

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NCT04359186

SCOPE Analytic Treatment Interruption Protocol

Recruiting
NAAges 18+InterventionalBasic science
University of California, San Francisco
~40 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Treatment Interruption Arm

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute retroviral syndrome
Measured over Week 0 through Month 6
+3 more outcomes measured
HIV/AIDS
1 sites across 1 states
California1
  • Steven Deeks, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

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Eligibility criteria

Inclusion

Willing and able to provide written informed consent
Age \>= 18
Documented HIV infection
Antiretroviral therapy for at least 12 months
Screening plasma HIV RNA levels below level of detection (\< 40-75 copies/mL), and all available determinations in past 12 months also below level of detection (blips allowed)
Screening CD4+ T-cell count \>350 cells/uL
If of childbearing potential, willing to use two methods of contraception
Willing to receive counseling regarding HIV transmission risk mitigation

Exclusion

Pregnant or plans to become pregnant during the course of the study
Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
Significant cardiovascular or cerebrovascular disease
Recent or prior (within past 5 years) malignancy
Severe kidney disease (CrCl \< 50 mL/min via Cockroft-Gault method)
Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
Concurrent treatment with immunomodulatory drugs
Unable or unwilling to use barrier protection or pre-exposure prophylaxis (PrEP) to prevent HIV transmission with sexual partners not known to be HIV-infected
  • 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