Long COVID studies
- Bay Area UCSF LIINC study
- National RECOVER study with sites across the US including UCSF
- National HIV Covid Recovery Study that can be done from home
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 our outreach coordinator Dan Berrner at 415 476 4082 ext 556 or firstname.lastname@example.org
- For COVID outpatient studies, please email email@example.com 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
Studies available for enrollment as of March 1, 2023:
The UCSF Brain Health study is looking for research participants to explore factors that influence the brain health of people living with HIV. We are looking for people living with HIV between the ages of 39-61. There are two study visits to complete the following study activities: urine test, vitals, blood draw, interview, and brain MRI. Cash payment is provided on completion of each study visit. For more information, please visit our website: https://healthybrainstudy.ucsf.edu/ or call 415-244-1204.
STUDIES FOR COVID-19 TREATMENT AND PREVENTION
v OPEN NOW: 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 LOW risk for disease progression and/or hospitalization.
Individuals are considered low risk if the following do NOT apply to them:
- HTN (on daily medication)
- 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).
v COMING SOON : Oral remdesivir prodrug for treatment of COVID-19 in standard risk outpatients. within 3 days of COVID symptom onset and test positivity:
A Phase 3 randomized, placebo-controlled trial of an investigational oral remdesivir analogue twice daily for 5 days for people without risk factors for severe COVID and not already on oral antiviral therapy. 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 :
v ENROLLING: A Phase 3, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in Participants With HIV-1 Who Are Virologically Suppressed on Antiretroviral Therapy: People living with HIV who take oral anti-hiv medications and have a suppressed viral load for at least 3 months will be randomized to either stay on their current medications, or start an investigational combination pill containing 100 mg of Doravirine and 0.25 mg of Islatravir (DOR/ISL) daily for 48 weeks. After 48 weeks all participants will take DOR/ISL for an additional 48 weeks. Participants will be followed for 2 years. Exclusionary criteria include: Active Hepatitis B infection, history of HIV virologic failure on any regimen, or known Doravirine mutations.
v ENROLLING: DORAVIRINE FOR PEOPLE WITH EXCESSIVE WEIGHT GAIN ON INTEGRASE INHIBITORS AND TENOFOVIR ALAFENAMIDE (THE DO-IT STUDY, A5391) 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
v ENROLLING: CMV VACCINATION FOR PEOPLE LIVING WITH HIV AND CMV AB (+) (ACTG 5355) Phase 2, double blind, placebo controlled study evaluating a novel CMV Vaccine (Modified Vaccinia Ankara) for people with HIV and CMV antibody (+) without active CMV disease. CMV Ab status can be evaluated during screening if status is unknown. The goal of the study is to understand the safety, immune response and impact on inflammation. Inclusion criteria include current CD4 > 250, nadir ≥100, and HIV virologically suppressed on ART.
v ENROLLING – HIV CURE STRATEGY STUDY: IL-15 SUPERAGONIST N-803 GIVEN WITH OR WITHOUT IV BROADLY NEUTRALIZING ANTIBODIES (bNAbs) (A5386) 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.
v ENROLLING INJECTABLE CABOTEGRAVIR+RILPIVIRINE FOR INDIVIDUALS WHO HAVE BEEN NON-ADHERENT TO ORAL ART (A5359): 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.
VIRAL HEPATITIS STUDIES:
v ENROLLING A5394: Safety, Tolerability, and Impact of Oral TLR8 Agonist Selgantolimod on HBsAg in Participants with Both Chronic Hepatitis B and HIV
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.
v ENROLLING: PD-1 inhibitor in individuals with chronic HBV on suppressive HBV antiviral therapy (HBV-monoinfection only) (ACTG 5368): Adults with chronic HBV infection (HBV surface antigen positive) who have HBV DNA suppression on oral nucleot(s)ide therapy will receive infusion of open label PD-1 inhibitor (cemiplimab) at two time points. Note: Participants are no longer required to undergo a study provide liver biopsy twice during the study. HIV co-infection is exclusionary.