SCOPE Analytic Treatment Interruption Protocol

University of California, San Francisco40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

HIV/AIDS

Interventions

Treatment Interruption ArmOTHER

Individuals with HIV on suppressive ART will interrupt their ART.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Acute retroviral syndrome

The proportion of participants developing acute retroviral syndrome

Time frame: Week 0 through Month 6

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

Time frame: Week 0 through Month 12

CD4+ T cell decline

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

Time frame: Week 0 through Month 6

Time to rebound

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

Time frame: Week 0 through Month 6

Central Contacts

Steven Deeks, MD

CONTACT

415-476-4082 steven.deeks@ucsf.edu

Michael Peluso, MD

CONTACT

415-476-9363 michael.peluso@ucsf.edu

Data from ClinicalTrials.gov

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