SCOPE Analytic Treatment Interruption Protocol (SCOPE-ATI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04359186|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 28, 2022
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Other: Treatment Interruption Arm||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Analytic Treatment Interruption in HIV Infection|
|Actual Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2024|
|Experimental: Treatment Interruption Arm||
Other: Treatment Interruption Arm
Individuals with HIV on suppressive ART will interrupt their ART.
- Acute retroviral syndrome [ Time Frame: Week 0 through Month 6 ]The proportion of participants developing acute retroviral syndrome
- Failure to re-suppress [ Time Frame: Week 0 through Month 12 ]The proportion of participants who fail to re-suppress to plasma HIV RNA levels <50 copies/mL after re-initiating ART
- CD4+ T cell decline [ Time Frame: Week 0 through Month 6 ]The proportion of participants with confirmed decreases in CD4+ T cell count below 350 cells/uL
- Time to rebound [ Time Frame: Week 0 through Month 6 ]The time between the treatment interruption and plasma HIV RNA >200 copies/mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359186
|Contact: Steven Deeks, MD||415-476-4082 ext firstname.lastname@example.org|
|Contact: Michael Peluso, MDemail@example.com|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94110|
|Contact: Rebecca Hoh firstname.lastname@example.org|
|Principal Investigator:||Steven Deeks, MD||University of California, San Francisco|