Long COVID studies
- Bay Area UCSF LIINC study
- National RECOVER study with sites across the US including UCSF
Studies at UCSF / San Francisco General Hospital:
Clinical studies available at the Z SF General Hospital ACTG & HHRC Units can be found on these websites: https://helpfighthiv.org/actg-studies/ and https://hividgm.ucsf.edu/open-clinical-trials. COVID vaccine study info can be found on: www.coronaviruspreventionnetwork.org.
- For non-COVID studies, you can contact outreach coordinator Dan Berrner at 415 476 4082 ext 556 or daniel.berrner@ucsf.edu
- For COVID outpatient studies, please email suzanne.hendler@ucsf.edu or call/text (415) 806-8554
- Instagram & Facebook: UCSF Infectious Disease Clinical Trials Center at ZSFG
- Twitter: @UCSFClinTrials
- Instagram & Facebook: UCSF Infectious Disease Clinical Trials Center
- For referrals, referring providers and potential participants can call/text 415-806-8554 or email ID-research.zsfg@ucsf.edu
Highlighted studies of April 15, 2024:
UCSF has just opened a Hepatitis C diagnostic study evaluating a fingerstick point of care test for HCV RNA- see below for details. We are also enrolling a study for transwomen living with HIV who are starting/restarting estradiol as gender-affirming therapy. See below:
HEPATITIS C RAPID DIAGNOSTIC STUDY
NOW OPEN: Clinical Evaluation of Xpert® HCV Test on the GeneXpert® Xpress System in a CLIA-Waived Environment (Cepheid) This study evaluates an investigational rapid fingerstick blood test for Hepatitis C viral load in comparison to standard FDA approved HCV viral load testing through a blood draw. Study will enroll participants 18 or over with a risk factor for hepatitis C infection including history of using drugs (injection or non-injection), living with HIV, born between 1945-1965, or man who is sexually active with men. Known untreated HCV or previous HCV infection are not exclusionary, however, cannot currently be taking active HCV treatment. Results from standard FDA approved testing for HCV viral load will be shared with participants. Results from the experimental fingerstick will not be shared. $100 compensation for one-time visit.
STUDIES FOR PEOPLE LIVING WITH HIV
NOW OPEN: Open label study of estradiol initiation/re-initiation in transwomen living with HIV (GET IT RIGHT STUDY, ACTG 5403): Phase IIB open label, non-randomized study of transwomen living with HIV who would like to initiate or re-initiate estradiol (after a two-week washout). The study will provide estradiol for up to 48 weeks and evaluate drug concentrations of estradiol and antiretroviral therapy. Inclusion criteria include currently taking or willing to switch to Biktarvy, Dolutegravir + TDF/FTC, or a Darunavir/cobicistat-containing regimen through routine care. Non-study provided estrogen, including injectable, are not permitted during the 48-week study. Anti-androgens, e.g., spironolactone, are prohibited at entry and ideally not taken during the first 24 weeks of the study.
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: Open label, randomized Study evaluating IM Cabotegravir given with IV or subcutaneous broadly neutralizing antibody VH3810109 (bnAb) (GSK sponsored study): Phase 2b study randomizing people living with HIV to one of three open label arms:1) IM Cabotegravir monthly + IV bNAb every 4 months, 2) IM Cabotegravir monthly + subcutaneous bNAb every 4 months, or 3) continuation of current oral regimen. Eligibility criteria include currently on 1st or 2nd ART regimen with a suppressed VL and have no history of virologic failure or active hepatitis B infection.
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 will be randomized to 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.
ENROLLING: INJECTABLE CABOTEGRAVIR+RILPIVIRINE FOR INDIVIDUALS WHO HAVE BEEN NON-ADHERENT TO ORAL ART (ACTG 5359): Phase III study of ART experienced individuals with HIV RNA >200 and evidence of ART non-adherence and no evidence of cabotegravir or rilpivirine resistance. All participants will receive oral ART x 24 weeks with conditional economic incentives to attain HIV suppression. Those who are suppressed at 24 weeks will be randomized to IM CAB+RIL every 4 weeks (after an oral lead-in) vs continued oral ART for 48 weeks.
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:
v 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.
SUSPECTED/CONFIRMED MPOX:
v Tecovirimat for Human Monkeypox (MPX) Virus (STOMP Trial, ACTG A5418):
A phase 3 trial evaluating the safety and efficacy of weight-based tecovirimat given for 14 days for the treatment of MPX. Patient with non-severe disease will be randomized to tecovirimat vs. blinded control; if disease or pain progress, participants can roll over to the open label treatment. Open label tecovirimat will be given to children, persons with pregnancy, those with severe disease, severe immune suppression, or severe skin conditions. Eligible participants should have presumed or confirmed MPX with symptoms of <14 days duration. https://www.stomptpoxx.org/main