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RecruitingNot ApplicableNCT04359186

SCOPE Analytic Treatment Interruption Protocol

Analytic Treatment Interruption in HIV Infection

Sponsor

University of California, San Francisco

Enrollment

40 participants

Start Date

Oct 15, 2020

Study Type

INTERVENTIONAL

Conditions

HIV/AIDS

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria10

  • 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

Interventions

OTHERTreatment Interruption Arm

Individuals with HIV on suppressive ART will interrupt their ART.

Locations(1)

University of California San Francisco

San Francisco, California, United States

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NCT04359186

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