RECRUITING

SCOPE Analytic Treatment Interruption Protocol

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Conditions

HIV/AIDSHIVAntiretroviral therapyHIV reservoirBiomarkers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Analytic Treatment Interruption in HIV Infection

Quick Facts

Study Start:2020-10-15
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04359186

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to provide written informed consent
  2. * Age \>= 18
  3. * Documented HIV infection
  4. * Antiretroviral therapy for at least 12 months
  5. * 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)
  6. * Screening CD4+ T-cell count \>350 cells/uL
  7. * If of childbearing potential, willing to use two methods of contraception
  8. * Willing to receive counseling regarding HIV transmission risk mitigation
  1. * Pregnant or plans to become pregnant during the course of the study
  2. * Active hepatitis B, defined as (1) positive sAg or (2) positive cAb with negative sAb and positive HBV DNA
  3. * Active hepatitis C, defined as positive Hep C Ab with positive HCV RNA
  4. * Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
  5. * Significant cardiovascular or cerebrovascular disease
  6. * Recent or prior (within past 5 years) malignancy
  7. * Severe kidney disease (CrCl \< 50 mL/min via Cockroft-Gault method)
  8. * Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
  9. * Concurrent treatment with immunomodulatory drugs
  10. * 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

Contacts and Locations

Study Contact

Steven Deeks, MD
CONTACT
415-476-4082
steven.deeks@ucsf.edu
Michael Peluso, MD
CONTACT
415-476-9363
michael.peluso@ucsf.edu

Principal Investigator

Steven Deeks, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-15
Study Completion Date2026-06

Study Record Updates

Study Start Date2020-10-15
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • HIV/AIDS
  • Antiretroviral therapy
  • HIV reservoir
  • Biomarkers

Additional Relevant MeSH Terms

  • HIV/AIDS