SCOPE Analytic Treatment Interruption Protocol

Official title

Analytic Treatment Interruption in HIV Infection

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.

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.

Interventions

• Other Treatment Interruption Arm
  Individuals with HIV on suppressive ART will interrupt their ART.

Primary outcome measures

• Acute retroviral syndrome [Time frame: Week 0 through Month 6]
• Failure to re-suppress [Time frame: Week 0 through Month 12]
• CD4+ T cell decline [Time frame: Week 0 through Month 6]
• Time to rebound [Time frame: Week 0 through Month 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• University of California San Francisco — San Francisco

Publications

• Meanley S, Rodriguez Garcia L, Lisha NE, Ahmed A, Korolkova A, Figueroa T, Nguyen E, J Peluso M, Cohn LB, Deeks S, Dube K, Sauceda J. Exploring Stigma and Self-Image: Mixed-Methods Insights from HIV Cure-Related Research Participants Undergoing Analytical Treatment Interruptions. AIDS Patient Care STDS. 2025 Apr;39(4):151-159. doi: 10.1089/apc.2024.0254. Epub 2025 Feb 20. PMID 39973220

Identifiers

NCT: NCT04359186 · 20-30442

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗