Status:
RECRUITING
SCOPE Analytic Treatment Interruption Protocol
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Chan Zuckerberg Biohub
Conditions:
HIV/AIDS
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
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 vir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04359186
Start Date
October 15 2020
End Date
June 1 2026
Last Update
June 18 2024
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94110