Updated as of 10-24-2025
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
STUDIES FOR PEOPLE LIVING WITH HIV:
- NOW OPEN: TRIAL OF DASATANIB+ QUERCERTIN FOR PEOPLE WITH HIV ON ART X ≥10 YEARS AND ≥ 50 YEARS TO IMPROVE PHYSICAL FRAILTY AND CELLULAR SENESCENCE (ACTG 5426): This Phase 2 study will randomize PWH to oral dasatanib/quercertin vs placebo x 12 weeks. This combination of a kinase inhibitor and a flavonoid that have been shown to reduce frailty in small studies of people without HIV. Enrollment criteria include self-report of frailty, slow walking speed (will be tested at screening, walker/cane ok), well controlled HIV. Exclusion criteria include HIV protease inhibitors, active malignancy, cirrhosis, MI or stroke within 6 months
- 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/
- COMING SOON: MENOPAUSAL HORMONE THERAPY FOR WOMEN LIVING WITH HIV (ACTG 5242) Phase 4, randomized, double-blind, placebo-controlled, parallel trial of hormone therapy with transdermal estradiol (with or without oral progesterone, depending on intact uterus status) versus placebo for women living with HIV in the late menopausal transition or early postmenopause with moderate or severe vasomotor symptoms. Cis-gender women age 40-60, on ART for ≥ 48 weeks, will be randomized to hormone replacement therapy (HRT) vs blinded placebo for 12 weeks to evaluate HRT impact on vasomotor symptoms.
- COMING SOON- Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV (ACTG 5402): Phase II, randomized, open-label, two-arm clinical trial evaluating the safety of the dopamine agonist pramipexole vs. the SSRI escitalopram (Lexapro) major depressive disorder with or without mild neurocognitive disorder in person with HIV. Inclusion criteria include stable ART for at least 90 days with viral load <200 and not currently on antidepressant therapy. Study duration is 24 weeks.
STUDIES FOR PEOPLE TAKING HIV PREP
- 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/
STUDIES OF COVID VACCINATION
OPENING SOON: SINGLE ARM, OPEN LABEL STUDY EVALUATING THE SAFETY AND IMMUNOGENICITY OF A NOVEL INTRAMUSCULAR COVID-19 BOOSTER VACCINE (DMID 25-1106): This Phase 1 study will enroll healthy, non-immunocompromised participants 18-64, who have previously received standard COVID vaccination to receive a single IM dose of a monoclonal recombinant subunit vaccine (IgG-Fd-Receptor Binding Domain fusion antigen targeting the Kp.2 variant of SARS-CoV-2). Last COVID vaccine should be at least 16 weeks prior to enrollment. Prior investigational vaccines are permitted as long as > 60 days prior to enrollment.