SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

HIV/AIDS

Treatments

Other: Treatment Interruption Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT04359186

20-30442

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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