East Bay Getting to Zero
Categories:
Hepatitis, HIV treatment, Research
Download DOC (55.5 KB)

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 February 5, 2021:

STUDIES FOR HIV INFECTED PATIENTS:  

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.

INJECTABLE CABOTEGRAVIR WITH NEUTRALIZING MONOCLONAL ANTIBODY (ACTG 5357): Phase II study injectable cabotegravir given every 4 weeks along with an infusion of a broadly neutralizing monoclonal antibodies (bNABS) every 8 weeks for 36 weeks. Participants will first be transitioned to oral cabotegravir/NRTIs for 4 weeks to ensure tolerance. Eligibility includes HIV suppression on ART for at least 2 years

STUDIES FOR PREVENTION OF SEXUALLY TRANSMITTED DISEASES

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) https://depts.washington.edu/doxypepstudy/

STUDIES FOR COVID-19

OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2) : Phase 2/3 platform trial of treatments for outpatients with newly diagnosed COVID. Currently providing a single infusion of monoclonal antibodies vs.  placebo for people with a diagnosis of COVID and symptom onset of less than 10 days.  Safe transportation will be provided for patients during the isolation time period. More information available at www.riseabovecovid.com and call/text (415) 806-8554 (English/Spanish)

COMING SOON: COVID VACCINES STUDIES:  We are looking for volunteers without a known prior history of COVID who have an increased risk of COVID infection and/or an increased risk of serious COVID disease. The current vaccine is the Astra-Zeneca ChAdOx adenovirus vector vaccine, given in two doses.  2:1 randomization to vaccine vs. placebo.  Additional vaccine candidates will More information at www.coronaviruspreventionnetwork.org  and call/text (415) 806-8554 (English/Spanish)

VIRAL HEPATITIS STUDIES:

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)
  • Coming soon: 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. Participants are required to undergo a study provide liver biopsy twice during the study.  HIV co-infection is exclusionary.

COMING SOON: HBV Vaccination for HBV vaccine naïve and prior HBV vaccine non-responders who are living with HIV (ACTG 5379):  Adults living with HIV who have prior HBV vaccination without protective HBV S Ab titers(>10 mIU/ml) or who have never received HBV vaccination will be randomized 1:1 to receive HBV vaccination with HEPLISAV-B or Energix-B, and response to vaccination will be evaluated

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

STUDIES FOR HIV INFECTED PATIENTS:  

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.

COMING SOON:  ONE MONTH OF LATENT TB TREATMENT WITH INH/RIFAPENTINE FOR HIV+ INDIVIDUALS TAKING DOLUTEGRAVIR (A5372) This is a drug interaction study which will evaluate the pharmacokinetics of dolutegravir during one month of LTBI treatment with INH/Rifapentine. An additional 50 mg dose will be given daily in the first phase of the study. Participants will have two separate days (day 0 and day 28) with intensive PK evaluations, conducted in a clinical research center

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/

STUDIES FOR COVID-19

OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2) : Phase 2/3 platform trial of treatments for outpatients with newly diagnosed COVID. Currently providing a single infusion of monoclonal antibodies vs. placebo for people with a diagnosis of COVID and symptom onset of less than 8 days. Will include multiple additional agents shortly including oral therapy (camostat), inhaled interferon, and an IM monoclonal antibody.  Safe transportation will be provided for patients during the isolation time period. More information available at www.riseabovecovid.com and call/text (415) 806-8554 (English/Spanish) or

VIRAL HEPATITIS STUDIES:

v 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 HBV Vaccination for HBV vaccine naïve and prior HBV vaccine non-responders who are living with HIV (ACTG 5379):  Adults living with HIV who have 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. Those or who have never received HBV vaccination will also be enrolled in an open label arm of HEPLISAV.

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