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 regiments and long-acting injectable antiretroviral forumlations; acute HIV detection and treatment; Hepatitis treatments; novel treatments for addiction, infections or inflmmation related to chronic HIV; complications related to aging and HIV; and new approaches to improve and measure adherence to medical regimens. 

Updates (as of MAY 2021)

As we have a number of studies open for now for those with suppressed HIV viral load, we are happy to walk though study options with interested patients and what they may be eligible for- for more information on non-COVID studies, contact our outreach coordinator, Dan Berrner at 415 476 4082 ext. 556.

For COVID-related outpatient studies, please contact [email protected] or (415) 806-8554.

View a list of open clinical trials below.

COVID-19 Studies
STUDY BASIC ELIGIBILITY CRITERIA DESIGN CONTACT
ACTIV-2

Adults 18 and over who tested positive for COVID-19 (not more than 10 days ago) and are at home.

In addition, you must have at least 1 of the symptoms below within the last 24 hours: fever, sore throat, chills, body pain or muscle aches, headache, tiredness, trouble breathing or cough

Please visit https://www.riseabovecovid.org for more information

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. Includes multiple additional agents including oral therapy, inhaled interferon, IM monoclonal antibody, subQ monoclonal antibody, and bovine serum albumin.

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

Call or text:
(415) 806-8554 
(English or Spanish)

 

Studies for HIV-Infected Patients
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.

Dan Berrner
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

Enrollees in this observational study will undergo a number of observational assessments including questionnaires, neuropsychiatric testing, and evaluation of blood, hair, and spinal fluid. ​​​​​​

Dan Berrner
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. 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.

Dan Berrner
Call/text: (415) 535-9495
A5372 Eligible participants include people living with HIV between the ages of 18-65 who have tested positive for TB and are taking dolutegravir as a 3-drug regimen for HIV. Participants must have a viral load of < 50 copies/ml

ONE MONTH OF LATENT TB TREATMENT WITH INH/RIFAPENTINE FOR HIV+ INDIVIDUALS TAKING DOLUTEGRAVIR

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

Dan Berrner
Call/text: (415) 535-9495
ELICIT, A5383 To be eligible for this study, you must be over 40 years old, HIV-positive (with a viral load of < 40 copies/mL), currently on ART, and CMV-positive.

RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE ANTI-INFLAMMATORY EFFICACY OF LETERMOVIR (PREVYMIS) IN ADULTS WITH HIV-1 AND ASYMPTOMATIC CMV 

This is a phase 2, randomized, open-label, placebo-controlled, multicenter trial to evaluate the anti-inflammatory efficacy of letermovir, administered once daily for 48 weeks in adults with HIV and asymptomatic CMV, who are on ART-mediated suppression. Participants will be randomized 1:1 to receive either letermovir or placebo. A futility analysis will be performed after the first 40 participants, who have started study treatment, reach their 8-week study visit.

Dan Berrner
Call/text: (415) 535-9495
A5386 Eligible participants are between 18-65 years of age, are HIV-positive (with viral load of <50 coplies/mL), and on ART. For more details, please visit the clinical trials website. 

SAFETY, TOLERABILITY, AND EFFICACY OF IL-15 SUPERAGONIST (N-803) WITH AND WITHOUT COMBINATION BROADLY NEUTRALIZING ANTIBODIES TO INDUCE HIV-1 CONTROL DURING ANALYTIC TREATMENT INTERRUPTION

Participants will undergo leukapheresis, and a subset will also undergo optional rectal biopsy and/or lymph node fine needle aspirations (FNAs) (Step 1).

Participants will be randomized to either the N-803 only arm (Arm A) or the N-803 with combination bNAbs arm (Arm B) and will be followed for ~100 weeks.

Dan Berrner
Call/text: (415) 535-9495

 

Studies for the Prevention of Sexually Transmitted Diseases
STUDY BASIC ELIGIBILITY CRITERIA DESIGN CONTACT

DoxyPEP

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.

For more information, visit: https://depts.washington/edu/doxypepstudy

DoxyPEP

Phase IV study of doxycycline taken as a single 200 mg dose within 24-72 hours after condomless sexual contact. 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)

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.

Dan Berrner
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

Participants will be randomized 1:1 to receive HBV vaccination with HEPLISAV-B or Energix-B, and response to vaccination will be evaluated ​​​​​​.

Dan Berrner
Call/text: (415) 535-9495

 

 

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May 2021 Studies enrolling and coming soon