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SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)

Primary Purpose

HIV/AIDS

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment Interruption Arm

About this trial

This is an interventional basic science trial for HIV/AIDS focused on measuring HIV, HIV/AIDS, Antiretroviral therapy, HIV reservoir, Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Interruption Arm

Arm Description

Outcomes

Primary Outcome Measures

Acute retroviral syndrome

The proportion of participants developing acute retroviral syndrome

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

CD4+ T cell decline

The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL

Time to rebound

The time between the treatment interruption and plasma HIV RNA >200 copies/mL

Secondary Outcome Measures

Full Information

NCT ID

NCT04359186

First Posted

April 20, 2020

Last Updated

May 8, 2023

Sponsor

University of California, San Francisco

Collaborators

Chan Zuckerberg Biohub

1. Study Identification

Unique Protocol Identification Number

NCT04359186

Brief Title

SCOPE Analytic Treatment Interruption Protocol

Acronym

SCOPE-ATI

Official Title

Analytic Treatment Interruption in HIV Infection

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

Collaborators

Chan Zuckerberg Biohub

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV/AIDS

Keywords

HIV, HIV/AIDS, Antiretroviral therapy, HIV reservoir, Biomarkers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Interruption Arm

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Treatment Interruption Arm

Intervention Description

Individuals with HIV on suppressive ART will interrupt their ART.

Primary Outcome Measure Information:

Title

Acute retroviral syndrome

Description

The proportion of participants developing acute retroviral syndrome

Time Frame

Week 0 through Month 6

Title

Failure to re-suppress

Description

The proportion of participants who fail to re-suppress to plasma HIV RNA levels <50 copies/mL after re-initiating ART

Time Frame

Week 0 through Month 12

Title

CD4+ T cell decline

Description

The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL

Time Frame

Week 0 through Month 6

Title

Time to rebound

Description

The time between the treatment interruption and plasma HIV RNA >200 copies/mL

Time Frame

Week 0 through Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Steven Deeks, MD

Phone

415-476-4082

Ext

404

steven.deeks@ucsf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Peluso, MD

Phone

415-476-9363

michael.peluso@ucsf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Deeks, MD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Hoh

rebecca.hoh@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD

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SCOPE Analytic Treatment Interruption Protocol

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