NCT04359186Recruiting
SCOPE Analytic Treatment Interruption Protocol
Analytic Treatment Interruption in HIV Infection
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Apr 2020
- Start date
- Oct 2020
- Primary completion date
- Dec 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT04359186
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Oct 2020 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of a non-nucleoside reverse transcriptase inhibitor and unable to switch regimen
- Recent or prior (within past 5 years) malignancy
- Concurrent treatment with immunomodulatory drugs
Other illness
- 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
- Significant cardiovascular or cerebrovascular disease
- Severe kidney disease (CrCl \< 50 mL/min via Cockroft-Gault method)
- Severe hepatic impairment (Child-Pugh Class C) or unstable liver disease
- 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
Other
- Pregnant or plans to become pregnant during the course of the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.