NCT04359186 · University of California, San Francisco
SCOPE Analytic Treatment Interruption Protocol
(SCOPE-ATI)
What this study is about
The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.
View original scientific description
The goal of this study is to understand the interaction between HIV and the host at the earliest stages when HIV medications are paused. Volunteers with HIV will interrupt antiretroviral therapy (ART) and then have intensive studies preformed two to three times per week. Most will resume therapy within three weeks, even if the virus does not rebound during this time.
Interventions
OTHER
Treatment Interruption Arm
Individuals with HIV on suppressive ART will interrupt their ART.
Primary outcome measures
Acute retroviral syndrome
Time frame: Week 0 through Month 6
The proportion of participants developing acute retroviral syndrome
Failure to re-suppress
Time frame: Week 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 decline
Time frame: Week 0 through Month 6
The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL
Time to rebound
Time frame: Week 0 through Month 6
The time between the treatment interruption and plasma HIV RNA \>200 copies/mL
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Willing and able to provide written informed consent
- 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 criteria
- 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
Where
- San Francisco, California
Collaborators
Chan Zuckerberg Biohub
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations