SCOPE Analytic Treatment Interruption Protocol

Description

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

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Study Overview

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Study Details

Study 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.

Analytic Treatment Interruption in HIV Infection

SCOPE Analytic Treatment Interruption Protocol

Condition
HIV/AIDS
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco, San Francisco, California, United States, 94110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Steven Deeks, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2026-06