East Bay Getting to Zero
Categories:
COVID, Hepatitis, HIV treatment, Research, STIs

Updated as of 1-9-2025

For referrals, referring providers and potential participants can call/text 415-806-8554 or email ID-research.zsfg@ucsf.edu

Check out the division website for more information about these and other studies, including links to dowloadable IRB approved flyers by clicking on the study name/number: https://hividgm.ucsf.edu/open-clinical-trials

Follow us on social media for updates!

  • Instagram & Facebook: UCSF Infectious Disease Clinical Trials Center at ZSFG
  • Bluesky (new!): @sfidrc.bsky.social

STUDIES FOR PEOPLE LIVING WITH HIV:  

  • ENROLLING: OBSERVATIONAL STUDY FOR PEOPLE WITH NEW CONFIRMED OR SUSPECTED HIV INFECTION AFTER USE OF INJECTABLE CABOTEGRAVIR FOR AS HIV PREP (ACTG 5321- Group 6):  People who have used injectable cabotegravir for PREP within 90 days of a blood sample concerning for possible HIV infection will be followed in an observational study to characterize the HIV reservoir, inflammatory consequences, and viral evolution after breakthrough infection, including after ART initiation.  Exclusionary criteria include HIV RNA > 1000 copies and current ART.   Participants will also be referred to the SeroPrep study https://seroprep.ucsf.edu/
  • ENROLLING: Intervention for Virologic Supression in Youth or the iVY Study. The iVY Study is a paid program at UC San Francisco designed to support 18-29-year-olds living with HIV in California to improve their overall health and well-being. Participation is fully remote and includes online surveys, video counseling sessions and testing an app. You could earn anywhere from $470 to $530. Fill out a brief survey to see if you qualify: https://redcap.link/coneqdti Call, text or email the team at 415-735-1507 or ivy@ucsf.edu & find out more at ivy.ucsf.edu.
  • ENROLLING: Women SHINE. A research study sponsored by UC San Digeo aimed at helping women living with HIV to access and stay engaged in HIV care. Women SHINE is currently enrolling women living with HIV who have experienced violence during their adult life. Women SHINE is a web-based peer navigation intervention to help cisgender women living with HIV/AIDS improve their engagement in HIV care and enhance their mental well-being. The overall goal of the study is to improve engagement in HIV care (e.g., improvement in HIV/AIDS medication adherence) and mental well-being (e.g., improvements in PTSD symptoms, emotion regulation and reduce stigma). However, the intervention now includes access to one-on-one peer navigation sessions, weekly group sessions, and access to resources and social support in California, Nevada, and Arizona, as well as, fully-support all Spanish Language services. Expected enrollment is open through December 2025.  

CURE STRATEGY STUDIES FOR PEOPLE LIVING WITH HIV :  

  • ENROLLING – HIV CURE STRATEGY STUDY: IL-15 SUPERAGONIST N-803 GIVEN WITH OR WITHOUT IV BROADLY NEUTRALIZING ANTIBODIES (bNAbs) (ACTG 5386)   People living with HIV with a suppressed viral load for at least 2 years will receive the subcutaneous IL-15 superagonist every 3 weeks for 8 injections, and may receive bNAb infusion (10-1074 and VRC-7-523LS) administered twice after confirming susceptibility to these antibodies. Participants will undergo an analytic treatment interruption with ART stopped at week 30, for up to 24 weeks.
  • COMING SOON- HIV CURE STRATEGY STUDY: TRIMER VACCINATION TO INDUCE BROADLY NEUTRALIZING ANTIBODY RESPONSE (ACTG 5422):  People living with HIV on ART for at least 2 years and with a suppressed viral load for at least 1 year will be randomized to receive an intramuscular vaccine a stabilized trimeric envelope glycoprotein vs. placebo 5 times over 52 weeks, with an additional year of follow-up. There will be no analytic treatment interruption.  Exclusion criteria include prior HIV vaccine within 1 year and HIV bNabs within 2 years prior to study entry.

STUDIES FOR PEOPLE TAKING HIV PREP

  • ENROLLING: OBSERVATIONAL STUDY FOR PEOPLE WITH NEW CONFIRMED OR SUSPECTED HIV INFECTIN AFTER USE OF INJECTABLE CABOTEGRAVIR FOR AS HIV PREP (ACTG 5321- Group 6):  People who have used injectable cabotegravir for PREP within 90 days of a blood sample concerning for possible HIV infection will be followed in an observational study to characterize the HIV reservoir, inflammatory consequences, and viral evolution after breakthrough infection, including after ART initiation.  Exclusionary criteria include HIV RNA > 1000 copies and current ART.   Participants will also be referred to the SeroPrep study https://seroprep.ucsf.edu/

VIRAL HEPATITIS STUDIES:

HEPATITIS B: MONO AND CO-INFECTION

  • ENROLLING: Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with Both Chronic Hepatitis B and HIV (A5394)

Phase II, double-blind, randomized, placebo-controlled trial to assess safety and effectiveness of Selgantolimod administered orally once a week for 24 weeks. Selgantolimod is an oral immunomodulator (toll-like receptor 8 agonist), given once weekly, in addition to ongoing HBV-active antiretroviral therapy.  Eligibility includes suppressed HIV and HBV viral loads, surface antigen (HBsAg) positive, on a regimen for both HIV and HBV for > 5 years, CD4 count > 350 cells/mm3, no active hepatitis C or recent treatment of hepatitis C.

  • COMING SOON: EFFICACY OF DUAL THERAPY WITH siRNA AND MONOCLONAL ANTIBODY (mAb) TO TREAT CHRONIC HBV IN PEOPLE LIVING WITH OR WITHOUT HIV, WITHOUT CIRRHOSIS (ACTG 5423)

Phase II, open label, randomized trial to assess effectiveness of HBV therapy with an siRNA and a mAb, both given subcutaneously.  Participants will be randomized to a lead-in strategy with mAb, followed by dual therapy with mAb and siRNA,  vs concurrent dual therapy.  Participants without HBV may be eligible for NRTI discontinuation if meet criteria.  Eligibility includes suppressed HIV (if living with HIV) and HBV viral loads, surface antigen (HBsAg) positive, on a regimen for both HIV and HBV for 1 year, CD4 count > 350 cells/mm3, and no previous diagnosis of advanced fibrosis or cirrhosis, by available imaging, biopsy or/and serologic fibrosis score.