Actively Recruiting
Observational PIC Destination Cohort
Led by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Updated on 2024-12-13
30
Participants Needed
4
Research Sites
284 weeks
Total Duration
On this page
Sponsors
A
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being done to see if people who control HIV without antiretroviral therapy (ART) after receiving an intervention can remain off ART safely. The information collected in this study is also being used to try to understand how people control HIV without ART after receiving an intervention.
CONDITIONS
Official Title
Observational PIC Destination Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Currently or previously enrolled in a qualifying ACTG or non-ACTG parent study of curative or suppressive HIV therapy that included an ATI
- If possible, not co-enrolled in the parent study after entering this study
- Achieved at least 24 weeks of HIV suppression following ATI initiation
- Remains off ART with less than 4 consecutive weeks of HIV-1 RNA over 1000 copies/mL
- CD4+ T-cell count over 350 cells/mm3 measured within 28 days before study entry
- Not experiencing symptoms of acute retroviral syndrome
- Willing to continue ATI for up to 96 weeks or until ART restart criteria are met, and remain in follow-up for 48 weeks after ART restart
- For participants able to become pregnant: negative pregnancy test within 24 hours before study entry
- For participants able to become pregnant and sexually active: agree to use one highly effective method of contraception during the study
- Willing to use barrier protection during sexual activity with partners not on effective PrEP throughout Step 1 ATI and until viral re-suppression in Step 2
- Ability and willingness to provide informed consent
You will not qualify if you...
- Intercurrent illness, new medical diagnosis, lab abnormality, sign, or symptom that increases risk during continued ATI as judged by site investigator
- Medical or psychiatric condition, including pregnancy or breastfeeding, that increases risk or interferes with study adherence as judged by site investigator
- For Step 2: any medical or psychiatric condition that increases risk or interferes with adherence as judged by site investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California, San Francisco HIV/AIDS CRS (801)
San Francisco, California, United States, 94110
Actively Recruiting
2
Washington University Therapeutics (WT) CRS (2101)
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Weill Cornell Upton CRS (7803)
New York, New York, United States, 10065
Actively Recruiting
4
Case CRS (2501)
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
A
ACTG ClinicalTrials.gov Coordinator
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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