Observational PIC Destination Cohort

Part of paid clinical trials in San Francisco, California.

Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study ID
NCT05985642
Status
Recruiting
Apply to this trial

Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 19, 2024
Status verified
Dec 2024
Primary completion
Jul 3, 2029
Completion
Sep 3, 2029

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Observational PIC Destination Cohort
    Step 1: Continued analytical treatment interruption (ATI) - During Step 1, PICs will be monitored for safety (including liver function, creatinine, pregnancy, and STI testing), viral, immune, neuropsychological, and socio-behavioral outcomes for up to 96 weeks of continued ATI. Step 2: ART Restart - Participants will begin Step 2 if they meet ART restart criteria or reach week 96. Participants will be monitored for safety (including liver function, creatinine, and pregnancy), immune, viral, neuropsychological, and socio-behavioral outcomes through 48 weeks after ART restart.

Primary Outcome Measure

Occurrence of an SAE or Grade ≥3 AE that is related to ATI [ Time Frame: From study entry to 96 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, San Francisco HIV/AIDS CRS (801)San FranciscoCalifornia94110
Jay Dwyer, RN, ACRN, BA
[email protected]
415-535-9495
Annie Luetkemeyer, MD
Washington University Therapeutics (WT) CRS (2101)St LouisMissouri63110
Michael Klebert, RN, PhD
[email protected]
314-454-0058
Rachel Presti, MD, PhD
Weill Cornell Upton CRS (7803)New YorkNew York10065
Jonathan Berardi, MS, APRN, FNP-C
[email protected]
(212) 746-4166
212-746-7864
Marshall J. Glesby, MD
Case CRS (2501)ClevelandOhio44106
Julie Pasternak, BSN
[email protected]
216-844-2738
Jeffrey Jacobson, MD

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco HIV/AIDS CRS (801)· San Francisco, CAWashington University Therapeutics (WT) CRS (2101)· St Louis, MOWeill Cornell Upton CRS (7803)· New York, NYCase CRS (2501)· Cleveland, OH

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