SCOPE Analytic Treatment Interruption Protocol

a study on HIV/AIDS Immunodeficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Steven Deeks, MD
Headshot of Steven Deeks
Steven Deeks

Description

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) 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.

Official Title

Analytic Treatment Interruption in HIV Infection

Details

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.

Keywords

HIV/AIDS, HIV, Antiretroviral therapy, HIV reservoir, Biomarkers, Acquired Immunodeficiency Syndrome, HIV Infections, Treatment Interruption Arm

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Steven Deeks, MD
    Steven G. Deeks, MD, is a Professor of Medicine in Residence at the University of California, San Francisco (UCSF) and a faculty member in the Division of HIV, Infectious Diseases and Global Medicine at Zuckerberg San Francisco General Hospital. Dr. Deeks has been engaged in HIV research and clinical care since 1993.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04359186
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated
Contact us about this trial