SCOPE Analytic Treatment Interruption Protocol
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.
Conditions:
🦠 HIV/AIDS
🗓️ Study Start (Actual) 15 October 2020
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 April 2020
  • First Submitted that Met QC Criteria 20 April 2020
  • First Posted 24 April 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 18 June 2024
  • Last Verified June 2024