SCOPE Analytic Treatment Interruption Protocol

NCT ID: NCT04359186

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2028-06-30

Brief Summary

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.

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Treatment Interruption Arm

Group Type: EXPERIMENTAL

Treatment Interruption Arm

Intervention Type: OTHER

Individuals with HIV on suppressive ART will interrupt their ART.

Interventions

Treatment Interruption Arm

Individuals with HIV on suppressive ART will interrupt their ART.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chan Zuckerberg Biohub

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Deeks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Deeks, MD

Role: CONTACT

steven.deeks@ucsf.edu

415-476-4082 ext. 404

Michael Peluso, MD

Role: CONTACT

michael.peluso@ucsf.edu

415-476-9363

Facility Contacts

Rebecca Hoh

Role: primary

rebecca.hoh@ucsf.edu

Other Identifiers

20-30442

Identifier Type: -

Identifier Source: org_study_id