Open Clinical Studies

The world-class care provided at Ward 86 is driven by research.

Ongoing research topics include new treatments for HIV, including simplified regimens and long-acting injectable antiretroviral formulations; acute HIV detection and treatment; Hepatitis treatments; novel treatments for addiction, infections or inflammation related to chronic HIV; complications related to aging and HIV; and new approaches to improve and measure adherence to medical regimens. 

Updates (as of JUNE 2022)

We have a number of studies open now for patients with HIV experiencing weight gain on integrase inhibitors, studies of CMV vaccination, as well as CMV oral therapy in HIV.  

Our outpatient COVID treatment study is now OPEN again for those at higher risk of progression to severe disease and provides an open label active comparator of the Regeneron monoclonal antibodies. Prior COVID vaccination is not exclusionary. More information below.  

Please contact us if you would like more details on any of these studies.

  • For non-COVID studies, you can contact our outreach coordinator Dan Berrner at (415) 535-9495 or [email protected]
  • For COVID outpatient studies, please email:  [email protected] 

View a list of open clinical trials from our division below: 

COVID-19 Studies
STUDY BASIC ELIGIBILITY CRITERIA DESIGN CONTACT
ACTIV-2d/SCORPIO-HR

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

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. 

Safe transportation will be provided for patients during the infectious time period.

Email:

 [email protected] 

COVAIL Participants need to have completed 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.

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 prototype, as well as combinations of   Beta/Omicron, Delta/Omicron,& Omicron/ prototype). 

Email:

 [email protected] 

 

Studies for People Living With HIV
STUDY BASIC ELIGIBILITY CRITERIA DESIGN CONTACT
The DO-IT Study, A5391 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.

DORAVIRINE FOR PEOPLE WITH EXCESSIVE WEIGHT GAIN ON INTEGRASE INHIBITORS AND TENOFOVIR ALAFENAMIDE

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.

Call/text: (415) 535-9495
A5321 Eligible participants include those on an uninterrupted fully active ART regimen, with at least two HIV-1 RNA values 20-1500 copies/mL within the previous 24 months, at least one HIV-1 RNA value 20-1500 copies/mL within the previous 12 months, and no values >1500 copies/mL within the previous 12 months

OBSERVATIONAL STUDY FOR PEOPLE WITH PERSISTENT LOW LEVEL VIREMIA DESPITE EFFECTIVE ART

This observational study will enroll those on an uninterrupted fully active ART regimen, with at least two HIV-1 RNA values 20-1500 copies/mL within the previous 24 months, at least one HIV-1 RNA value 20-1500 copies/mL within the previous 12 months, and no values >1500 copies/mL within the previous 12 months. Enrollees will undergo a number of observational assessments including questionnaires, neuropsychiatric testing, and evaluation of blood, hair, and spinal fluid.​​​​​​

Call/text: (415) 535-9495
A5359 ART-experienced individuals with HIV RNA >200 and evidence of ART non-adherence and no evidence of cabotegravir or rilpivirine resistance.

INJECTABLE CABOTEGRAVIR+RILPIVIRINE FOR INDIVIDUALS WHO HAVE BEEN NON-ADHERENT TO ORAL ART

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.

Call/text: (415) 535-9495
A5386 Eligible participants are between 18-70 years of age, are HIV-positive with a suppressed viral load for at least 2 years, and willing to stop taking ART. For more details, please visit the clinical trials website. 

HIV CURE STRATEGY STUDY: IL-15 SUPERAGONIST N-803 GIVEN WITH OR WITHOUT IV BROADLY NEUTRALIZING ANTIBODIES (bNAbs)

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.

Call/text: (415) 535-9495

ELICIT, A5383

To be eligible for this study, you must be over 40 years old, living with HIV (with a viral load of < 40 copies/mL), currently on ART, and CMV-positive.

CMV TREATMENT WITH ORAL LETERMOVIR IN PEOPLE WITH HIV AND ASYMPTOMATIC CMV

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.

Call/text: (415) 535-9495

 

A5355

To be eligible, you must currently be living with HIV and are CMV antibody (+) with CD4 > 250, nadir ≥100, and virologically suppressed on ART.

CMV INVESTIGATIONAL 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 virology suppressed on ART.

Call/text: (415) 535-9495

 

 

Viral Hepatitis Studies
STUDY BASIC CRITERIA DESIGN CONTACT

ACTG 5380

Individuals with acute HCV

ACUTE HCV TREATMENT WITH 4 WEEKS of GLECAPREVIR/PIBRENTASVIR (HIV+ or HIV UNINFECTED)

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)

Call/text: (415) 535-9495

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

HBV VACCINATION FOR PRIOR HBV VACCINE NON-RESPONDERS WHO ARE LIVING WITH HIV

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.

Call/text: (415) 535-9495
A5368 Eligible participants are 18-70 years of age, weight between 40-200 kg, are on treatment for chronic Hepatitis B infection, and are not living with HIV.

ENROLLING: PD-1 INHIBITOR IN INDIVIDUALS WITH CHRONIC HBV ON SUPPRESSIVE HBV ANTIVIRAL THERAPY (HBV-MONOINFECTION ONLY

This is a Phase I/II study looking at the safety and immunotherapeutic activity of cemiplimab (PD-1 inhibitor) in participants with chronic HBV infection on tenofovir- or entecavir-based  suppressive oral nucleot(s)ide HBV therapy. Participants will receive infusion of open label IV cemiplimab at two time points and are required to undergo study provided liver biopsies at study entry and week 18. HIV co-infection, advanced fibrosis/cirrhosis, and active HCV infection are  exclusionary. 

Call/text: (415) 535-9495

 

Below are a list of open studies from the Center on Substance Use and Health in the San Francisco Department of Public Health:

Studies by the Center on Substance Use and Health (Updated October 15, 2021)
STUDY BASIC CRITERIA DESIGN CONTACT

Harness Study Logo

Harness

To see if you are eligible, please call us at 628.217.6333 A study testing whether an herbal supplement (Kudzu) taken on an as-needed basis can help to reduce someone’s alcohol use. Eligible participants are compensated between $10-$50 for a total of $444 over the course of the study.

Phone:
628.217.6333


Email

Website

Reboot 2.0 Study logo

Reboot 2.0

Eligible participants use illicit opioids and have been a recipient of naloxone.

To see if you are eligible, please call us at 628.217.6325

We are testing a counseling intervention to see if it could reduce someone’s overdose risk. Eligible participants are compensated between $10-$50 for a total of $392 over the course of the study.

Phone: 628.217.6325

Email

Website

PRIME Study Logo

PRIME

Eligible participants are men who have sex with men, use methamphetamine, and inject substances. To see if you are eligible, please call us at 628.217.6319 PRIME is a two-arm trial that is evaluating a strategy to support PrEP adherence in men who have sex with men, use methamphetamine and inject substances. All participants will receive open label Descovy (PrEP) and counseling during the study. Participants will be randomized 1:1 to receive video directly observed therapy (using a mobile app to submit videos taking their PrEP). Eligible participants are compensated up to $612 over the course of the study

Phone: 
628.217.6319

Email

Website

M3.0 Study Logo

M3.0

Eligible participants are currently experiencing methamphetamine use disorder. To see if you are eligible, please call us at 628.217.6319 M3.0 is a Phase 1 drug-drug interaction (safety) trial of mirtazapine for methamphetamine use disorder. Participation includes a 14-day hospital stay. The purpose is to determine if mirtazapine alters the cardiovascular response and pharmacokinetics to IV methamphetamine and to evaluate these in the presence of methadone use (12 participants meth/no opioid use, 12 meth/methadone maintenance). This study is dual site, San Francisco and Los Angeles. Eligible participants are compensated up to $2,430.

Phone:
628.217.6319

Email

Website