Open Clinical Studies

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] 

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] 

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.

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.​​​​​​

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.

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.

ELICIT, A5383

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.

A5355

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

ACTG 5380

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)

ACTG 5379

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.

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. 

Harness

Phone:
628.217.6333

Email

Website

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

Phone: 628.217.6325

Email

Website

PRIME

Phone: 
628.217.6319

Email

Website

M3.0

Phone:
628.217.6319

Email

Website