SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)

• ClinicalTrials.gov Identifier: NCT04359186
• Recruitment Status: Recruiting
• First Posted: April 24, 2020
• Last Update Posted: May 9, 2023
• Sponsor: University of California, San Francisco
• Collaborator: Chan Zuckerberg Biohub
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV/AIDS	Other: Treatment Interruption Arm	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Analytic Treatment Interruption in HIV Infection
• Actual Study Start Date: October 15, 2020
• Estimated Primary Completion Date: June 2024
• Estimated Study Completion Date: June 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Acute retroviral syndrome [ Time Frame: Week 0 through Month 6 ]
   The proportion of participants developing acute retroviral syndrome
2. 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
3. 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
4. Time to rebound [ Time Frame: Week 0 through Month 6 ]
   The time between the treatment interruption and plasma HIV RNA >200 copies/mL

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Steven Deeks, MD; 415-476-4082 ext 404; steven.deeks@ucsf.edu

Contact: Michael Peluso, MD; 415-476-9363; michael.peluso@ucsf.edu

Locations

United States, California

University of California San Francisco; Recruiting

San Francisco, California, United States, 94110

Contact: Rebecca Hoh rebecca.hoh@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

Chan Zuckerberg Biohub

Investigators

• Principal Investigator: Steven Deeks, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04359186
• Other Study ID Numbers: 20-30442
• First Posted: April 24, 2020
• Last Update Posted: May 9, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

HIV; HIV/AIDS; Antiretroviral therapy; HIV reservoir; Biomarkers

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases