SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)

Analytic Treatment Interruption in HIV Infection

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.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Other: Treatment Interruption Arm

Detailed Description

In this study, people living with HIV will undergo intensive sampling prior to and following an interruption of their antiretroviral therapy (ART). Individuals will be asked to resume ART once the virus is detectable, or after approximately three weeks if the virus remains undetectable.

Individuals who were able to control their virus before ART ("controllers") will be able to participate in an extended treatment interruption and have less restrictive ART restart criteria.

The overall goal of the study is to characterize the interaction between the host and the virus at the earliest stages of virus replication and to identify predictors of rebound before virus becomes detectable.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Deeks, MD; Phone Number: 404 415-476-4082; Email: Steven.Deeks@ucsf.edu
• Study Contact Backup: Name: Michael Peluso, MD; Phone Number: 415-476-9363; Email: michael.peluso@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • University of California San Francisco
      • Contact: Rebecca Hoh; Email: rebecca.hoh@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Interruption Arm	Other: Treatment Interruption Arm; Individuals with HIV on suppressive ART will interrupt their ART.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute retroviral syndrome	The proportion of participants developing acute retroviral syndrome	Week 0 through Month 6
Failure to re-suppress	The proportion of participants who fail to re-suppress to plasma HIV RNA levels <50 copies/mL after re-initiating ART	Week 0 through Month 12
CD4+ T cell decline	The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL	Week 0 through Month 6
Time to rebound	The time between the treatment interruption and plasma HIV RNA >200 copies/mL	Week 0 through Month 6

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Chan Zuckerberg Biohub
• Investigators: Principal Investigator: Steven Deeks, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 20, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Biomarkers; Antiretroviral therapy; HIV/AIDS; HIV reservoir
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20-30442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No