SCOPE Analytic Treatment Interruption Protocol
ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Willing and able to provide written informed consent
Age >= 18
Documented HIV infection
Antiretroviral therapy for at least 12 months
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Treatment Interruption Arm
Other interventionIndividuals with HIV on suppressive ART will interrupt their ART.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment Interruption ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute retroviral syndrome
The proportion of participants developing acute retroviral syndrome
Time frame
Week 0 through Month 62
Failure to re-suppress
The proportion of participants who fail to re-suppress to plasma HIV RNA levels \<50 copies/mL after re-initiating ART
Time frame
Week 0 through Month 123
CD4+ T cell decline
The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL
Time frame
Week 0 through Month 64
Time to rebound
The time between the treatment interruption and plasma HIV RNA \>200 copies/mL
Time frame
Week 0 through Month 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Chan Zuckerberg Biohub
Collaborator
Source ClinicalTrials.gov