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

Studies as of March 29, 2022:

New COVID studies opening soon:

  • COVID booster study for adults who have completed a full COVID vaccine series – participants will receive an additional open label booster with either a standard Moderna COVID vaccine or a combination variant vaccine. Prior COVID infection is not exclusionary and this study will be open to qualifying participants, including faculty and staff. 
  • Our outpatient COVID treatment study is opening again soon for those at higher risk of progression to severe disease and allows background standard of care treatment, including monoclonal antibodies and oral treatment after enrollment.  Prior COVID vaccination and/or infection are not exclusionary.

STUDIES FOR COVID-19 TREATMENT AND PREVENTION

OPENING SOON: TRIAL OF NOVEL COVID BOOSTING STRATEGIES IN FULLY VACCINATED ADULTS (COVAIL)

This NIH sponsored Phase 2 study evaluates the safety, immunogenicity and efficacy of different boosting strategies including the current Moderna COVID vaccine and several different combinations of variant vaccines (including Beta/Delta, Beta/Omicron, Delta/Omicron). Participants need to have complete an initial FDA approved vaccine series, including a booster with last dose > 4 months prior.  Prior COVID infection is not exclusionary but must be > 4 months prior. Immunocompromising conditions are exclusionary, however HIV infection permitted as long as well controlled on ART.  Email CovidVaccineSFGH@ucsf.edu or call/text (415) 806-8554.

OPENING SOON: OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2d/SCORPIO-HR) : Phase 3  randomized, placebo controlled trial of an investigational oral protease inhibitor given for 5 days.  Other standard of care COVID treatment including oral/inhaled/intravenous therapies permitted after enrollment as long as no drug interaction with the study drug. Paxlovid is prohibited due to drug interactions.  The study will enroll patients diagnosed with COVID and symptom onset ≤ 5 days who are at HIGHER risk for disease progression. Those at higher risk include: 

1) Not fully vaccinated with initial vaccine series with one or more risk factors including age ≥65, or age≥18 with HTN, CAD, COPD, BMI >30,  and/or diabetes

2) Regardless of vaccination status with one of the following:  Age ≥80, sickle cell disease, Parkinson’s disease, dementia, nursing home resident or immunompromising condition including cancer treatment, hematologic malignancy, stem cell transplant with past 2 year, untreated HIV or HIV with  CD4<200, combined 1o immunodeficiency, or on on immunosuppressants

Safe transportation will be provided for patients during the infectious time period. Call/text (415) 806-8554 (English/Spanish).

STUDIES FOR HIV INFECTED PATIENTS:  

NOW OPEN: 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.

NOW OPEN: 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:  SWITCH STUDY: MONTHLY CABOTEGRAVIR INJECTION PLUS IV bNAbs FOR PEOPLE WITH WELL CONTROLLED HIV (A5357) Single arm, Phase II open-label switch study to assess the safety and effectiveness of monthly IM Cabotegravir combined with every 8 weeks IV bNAbs (VRC07-523LS) given for up to 48 weeks. Eligibility includes stability on 3 drug ART regimen with VL < 50 for at least 2 years (one blip permitted), CD4 >350, no history of prior virologic failure, and no active HBV infection. Participants will be tested for susceptibility to the bNAbs during screening

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.

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.

STUDIES FOR PREVENTION OF SEXUALLY TRANSMITTED DISEASES

ENROLLING DoxyPEP: Phase IV study of doxycycline taken as a single 200 mg dose within 24-72 hours after condomless sexual contact.  Eligible individuals must be a man who has sex with men or a transgender woman, living with HIV or taking/starting HIV PrEP, with a history of gonorrhea, chlamydia or syphilis in the past year. Participants will be randomized 2:1 to receive open label doxycycline or continued standard of care for 12 months of follow-up.  Contact 415-939-4543 (Living with HIV, enrolled at ZSFG) or 415-855-0402 (PrEP patients, enrolled at SF City clinic) Also see website:  https://depts.washington.edu/doxypepstudy/

VIRAL HEPATITIS STUDIES:

v 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)

v 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

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