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
As of September 5, 2023:
There is one outpatient COVID treatment study for those at lower risk of severe disease progression who would not otherwise be treated– participants need to enroll within three days of symptom onset. UCSF can provide COVID appropriate transportation for study candidates.
Mpox treatment study: The STOMP study for Tpoxx mpox treatment is still enrolling, both in-person at UCSF as well as online with a remote only option if people aren’t able to go in.
There are two studies that focus specifically on WOMEN living with HIV:
- Doravirine-containing ART to potentially mitigate weight gain on INSTI & TAF containing ART (A5391)- enrolling people assigned female sex at birth
- Initiation/re-initiation of estradiol as gender-affirming therapy for transwomen taking or willing to switch to Biktarvy, dolutegravir + TDF/3TC, or Darunavir/cobicistat based ART (A5403)
STUDIES FOR COVID-19 TREATMENT AND PREVENTION
ENROLLING: OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2d/SCORPIO): A Phase 3 randomized, placebo-controlled trial of an investigational oral protease inhibitor given once a day for 5 days. The primary objective is to determine whether the oral antiviral will reduce the time to sustained symptom resolution. Other standard of care COVID treatments—including oral/inhaled/intravenous therapies—are permitted after enrollment if there are no drug interactions with the study drug and if they are indicated. Paxlovid is prohibited due to drug interactions. Participants must have tested positive for COVID < 3 days from study enrollment, and their symptoms must have begun < 3 days from enrollment. The study is enrolling those who are at standard risk for disease progression and/or hospitalization.
Individuals are considered standard risk if the following do NOT apply to them:
- HTN (on daily medication)
- CAD
- COPD (on daily medication)
- BMI >30 and/or Diabetes
- Sickle cell disease
- Parkinson’s disease, dementia, nursing home resident
- Any immunocompromising condition, including cancer treatment, hematologic malignancy, stem cell transplant with the past 2 years, untreated HIV or HIV with CD4<200
Vaccination status will not be considered for the eligibility assessment. Safe transportation will be provided for patients during the infectious period. Call/text (415) 806-8554 (English/Spanish).
STUDIES FOR PEOPLE LIVING WITH HIV :
OPENING SOON: 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 who would like to initiative estradiol or reinitiate estrogen (after a 2 week washout). The study will evaluate drug concentrations of estradiol and antiretroviral therapy. Inclusion criteria include currently taking or willing to switch to Biktarvy, Dolutegravir + TDF/FTC, or Darunavir/cobicistat through routine care. Non-study provided estrogen, including injectable, and anti-estrogens such as spironolactone are not permitted during the 24 week study.
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/
OPENING SOON: 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: DORAVIRINE FOR PEOPLE WITH EXCESSIVE WEIGHT GAIN ON INTEGRASE INHIBITORS AND TENOFOVIR ALAFENAMIDE (THE DO-IT STUDY, ACTG 5391) Phase 4, three arm, open label randomized study randomizing people living with HIV to stay on current INSTI based ART vs change to the NNRTI doravirine with Truvada (TDF/FTC) vs doravirine with Descovy (TAF/FTC) for 48 weeks. Eligibility includes BMI ≥ 30, currently taking an integrase inhibitor, and suppressed HIV VL for at least 48 weeks. Note: eligibility has been revised to remove the requirement for unintentional weight gain of > 10% in the 1-3 years. Currently open to enrollment for WOMEN only
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:
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 Selgantomlimod administered orally once a week for 24 weeks. Selgantomlimod 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.
Phase II, double-blind, randomized, placebo-controlled trial to assess safety and effectiveness of Selgantomlimod administered orally once a week for 24 weeks. Selgantomlimod 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.