Updated as of 5-5-2026
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 TAKING DOXY-PEP
- OBSERVATIONAL STUDY OF PEOPLE TAKING DOXYCYCLINE TO PREVENT SEXUALLY TRANSMITTED INFECTIONS (DOXYIMPACT): Observational study of men and women who are planning to start or who are already taking doxy-PEP/doxyPrEP. This study will look at real world effectiveness to reduce sexually transmitted infections and the potential impact of intermittent doxycycline use on antimicrobial resistance and on the microbiome. Participants may be living with or without HIV.
STUDIES FOR PEOPLE LIVING WITH HIV:
- Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) with or without 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) to treat major depressive disorder with or without mild neurocognitive disorder in people 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.
- 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 post menopause with moderate or severe vasomotor symptoms. Cis-gender women ages 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.
- ALENDRONATE IMPACT ON THE HIV RESERVOIR (ACTG 5428): This randomized placebo-controlled trial evaluates alendronate, an osteoporosis treatment that also is under investigation for potential HIV latency reversing properties. Participants will be randomized 2:1 to receive weekly oral alendronate vs placebo for 24 weeks with a primary endpoint of change in the HIV reservoir. Eligibility criteria include well-controlled HIV on ART ≤ 10 years , ≤65 years old and no known osteoporosis.
- 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/
- STUDY OF CHOLESTEROL LOWERING MEDICAITON IN PWH WITH KNOWN CVD OR RISK FACTORS (CLEAR-HIV Study) Double blinded, randomized trial evaluating at Bempedoic acid 180 mg taken orally once daily for one year compared to placebo in participants with HIV and heart disease or risk of heart disease. Additionally, the study is looking at whether Bempedoic acid compared to placebo improves vascular inflammation and plaque buildup in the arteries. Statin use is allowed (no start/stop of statin, or dose changes while on study). Contact 415 353-4347 or alexxis.levya@ucsf.
STUDIES FOR PEOPLE TAKING HIV PREP
- OBSERVATIONAL STUDY FOR PEOPLE WITH NEW CONFIRMED OR SUSPECTED HIV INFECTION AFTER USE OF INJECTABLE CABOTEGRAVIR OR LENACAPAVIR FOR HIV PREP (ACTG 5321- Group 6): People who have used injectable cabotegravir or LEN 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
- 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 enrolls 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.