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 September 22, 2020:
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