SCOPE Analytic Treatment Interruption Protocol

HIV/AIDS Clinical Trial

— SCOPE-ATI  

Official title:

Analytic Treatment Interruption in HIV Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359186
• Other study ID #: 20-30442
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: June 2026

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Steven Deeks, MD
• Phone: 415-476-4082
• Email: steven.deeks[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Other:
• Treatment Interruption Arm
Individuals with HIV on suppressive ART will interrupt their ART.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Chan Zuckerberg Biohub

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute retroviral syndrome	The proportion of participants developing acute retroviral syndrome	Week 0 through Month 6
Primary	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
Primary	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
Primary	Time to rebound	The time between the treatment interruption and plasma HIV RNA >200 copies/mL	Week 0 through Month 6