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SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359186
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Chan Zuckerberg Biohub
Information provided by (Responsible Party):
University of California, San Francisco

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.

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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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359186


Contacts
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Contact: Steven Deeks, MD 415-476-4082 ext 404 steven.deeks@ucsf.edu
Contact: Michael Peluso, MD 415-476-9363 michael.peluso@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Chan Zuckerberg Biohub
Investigators
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Principal Investigator: Steven Deeks, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04359186    
Other Study ID Numbers: 20-30442
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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