East Bay Getting to Zero
Categories:
COVID, Hepatitis, HIV treatment, Research, STIs

Long COVID studies

Studies at UCSF / San Francisco General Hospital

The 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 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

Studies as of August 8, 2022:

 STUDIES FOR COVID-19 TREATMENT AND PREVENTION

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 < 5 days from study enrollment, and their symptoms must have begun < 5 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:

  1. HTN (on daily medication)
  2. CAD
  3. COPD (on daily medication)
  4. BMI >30 and/or Diabetes
  5. Sickle cell disease
  6. Parkinson’s disease, dementia, nursing home resident
  7. 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 :  

ENROLLING: CMV TREATMENT WITH ORAL LETERMOVIR IN PEOPLE WITH HIV AND ASYMPTOMATIC CMV (ACTG 5383)  Phase 2 randomized open label placebo controlled study of 48 weeks of  letermovir, an oral antiviral active against CMV, in people living with HIV. The goal of the study is to look at the impact of CMV treatment on inflammation and detectable CMV.  Inclusion criteria include age ≥ 40, HIV suppressed on ART,  and CMV IgG (+) – serology can be tested as part of the study if not known.

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.

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 ≥ 27.5, unintentional weight gain of > 10% in the 1-3 years after starting an integrase inhibitor (bictegravir, raltegravir, dolutegravir), and suppressed HIV VL for at least 48 weeks.

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.

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:

ENROLLING Acute HCV treatment with 4 weeks of glecaprevir/pibrentasvir (HIV (+) or HIV uninfected) (ACTG 5380):  Individuals with acute HCV will receive open label G/P x 4 weeks.  Those who fail to attain an SVR12 will have the option to take study-provided retreatment. Acute HCV defined as

  • new ALT of ≥ 5x ULN or >250U/L if prior normal ALT or ≥ 10x ULN or >500 U/L  if baseline ALT abnormal or not available, OR
  • detectable HCV RNA with prior neg HCV Ab and undetectable HCV RNA in past 6 months (if no prior HCV infection)
  • detectable HCV RNA with prior undetectable HCV RNA in past 6 months (if prior known HIV infection)

ENROLLING HBV Vaccination for prior HBV vaccine non-responders who are living with HIV (ACTG 5379):  Adults living with HIV who have had prior HBV vaccination without protective HBV S Ab titers (>10 mIU/ml) will be randomized 1:1 to receive HBV vaccination with HEPLISAV-B or Energix-B, and response to vaccination will be evaluated. The arm for those who have never received HBV vaccination has now been closed

COMING SOON: Several studies evaluating HBV cure strategies in HBV mono-infected individuals on suppressive NRTI therapy. More information forthcoming