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 January 2024)

We have a number of studies open now for people living with HIV that includes cure research, injectable HIV treatment, as well as an M-POX treatment trial.

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

Call/text:  (415) 806-8554 or Email: [email protected]

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

Studies for People Living With HIV
STUDY BASIC ELIGIBILITY CRITERIA DESIGN CONTACT
A5321 Exclusionary criteria include HIV RNA > 1000 copies and current ART. 

OBSERVATIONAL STUDY FOR PEOPLE WITH NEW CONFIRMED OR SUSPECTED HIV INFECTION AFTER USE OF INJECTABLE CABOTEGRAVIR FOR HIV PREP (ACTG 5321- Group 6)

People who have used injectable cabotegravir for PREP within 90 days of a blood sample concerning for possible HIV infection will be followed in an observational study to characterize the HIV reservoir, inflammatory consequences, and viral evolution after breakthrough infection, including after ART initiation.

Participants will also be referred to the SeroPrep study:

https://seroprep.ucsf.edu/​​​​​​

Email:

[email protected] 

Call/text: (415) 806-8554

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 (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 4-24 weeks with conditional economic incentives to attain HIV suppression. Those who are suppressed at 4 weeks will be randomized to IM CAB+RIL every 4 weeks (after an oral lead-in) vs continued oral ART for 48 weeks.

Email:

[email protected] 

Call/text: (415) 806-8554

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.

Email:

[email protected] 

Call/text: (415) 806-8554

A5403

 

Get It Right Study

Inclusion criteria include currently taking or willing to switch to Biktarvy, Dolutegravir + TDF/FTC, or a Darunavir/cobicistat-containing regimen through routine care. 

Non-study provided estrogen, including injectable, are not permitted during the 48-week study. Anti-androgens, e.g., spironolactone, are prohibited at entry and ideally not taken during the first 24 weeks of the study.

OPEN LABEL STUDY OF ESTRADIOL INITIATION/RE-INITIATION IN TRANSWOMEN LIVING WITH HIV (GET IT RIGHT STUDY, ACTG A5403)

Phase IIB open label, non-randomized study of transwomen living with HIV who would like to initiate or re-initiate estradiol (after a two-week washout). The study will provide estradiol for up to 48 weeks and evaluate drug concentrations of estradiol and antiretroviral therapy

Email:

[email protected] 

Call/text: (415) 806-8554

GSK Embrace Eligibility criteria include currently on 1st or 2nd ART regimen with a suppressed VL and have no history of virologic failure or active hepatitis B infection.

OPEN LABEL, RANDOMIZED STUDY EVALUATING IM CABOTEGRAVIR GIVEN WITH IV OR SUBCUTANEOUS BROADLY NEUTRALIZING ANTIBODY VH3810109 (bnAb) (GSK sponsored study)

Phase 2b study randomizing people living with HIV to one of three open label arms: 1) IM Cabotegravir monthly + IV bNAb every 4 months, 2) IM Cabotegravir monthly + subcutaneous bNAb every 4 months, or 3) continuation of current oral regimen.

Email:

[email protected] 

Call/text: (415) 806-8554

 

 

Viral Hepatitis Studies
STUDY BASIC CRITERIA DESIGN CONTACT

A5394

Eligible participants should have presumed or confirmed MPX with symptoms of <14 days duration.

SAFETY, TOLERABILITY, AND IMPACT OF ORAL TLR8 AGONIST SELGANTOLIMOD ON HBSAG IN PARTICIPANTS WITH BOTH CHRONIC HEPATITIS B AND HIV

This is a phase II, double-blind, randomized, placebo-controlled trial to assess safety and effectiveness of Selgantomlimod when administered orally once a week for 24 weeks, in people living with HIV and chronic hepatitis B. Selgantomlimod is an oral immunomodulator (toll-like receptor 8 agonist), given once weekly, in addition to ongoing HBV-active antiretroviral therapy.  Eligibility includes suppressed HIV and HBV viral loads, surface antigen (HBsAg) positive, on a regimen for both HIV and HBV for > 5 years, CD4 count > 350 cells/mm3, no hepatitis C or recent treatment of hepatitis C, and between 18-70 years old.  

Email:

[email protected] 

Call/text: (415) 535-9495

Xpert HCV The purpose of this study is to evaluate the clinical performance of the Xpert HCV test by untrained users in a CLIA-waived setting.

This study evaluates an investigational rapid fingerstick blood test for Hepatitis C viral load in comparison to standard FDA approved HCV viral load testing through a blood draw.  Study will enroll participants 18 or over with a risk factor for hepatitis C infection including history of injection drug use, living with HIV, born between 1945-1965, or man who is sexually active with men.  Known untreated HCV or previous HCV infection are not exclusionary, however, cannot be taking active HCV treatment. Results from standard FDA approved testing for HCV viral load will be shared with participants. Results from the experimental fingerstick will not be shared.  $100 compensation for one-time visit.

Email:

[email protected] 

Call/text: 415-806-8554

M-Pox
STUDY BASIC CRITERIA DESIGN CONTACT

A5418

 

STOMP TRIAL

Eligibility includes suppressed HIV and HBV viral loads, surface antigen (HBsAg) positive, on a regimen for both HIV and HBV for > 5 years, CD4 count > 350 cells/mm3, no hepatitis C or recent treatment of hepatitis C, and between 18-70 years old.  

TECOVIRIMAT FOR HUMAN MONKEYPOX (MPX) VIRUS (STOMP TRIAL, ACTG A5418)

A phase 3 trial evaluating the safety and efficacy of weight-based tecovirimat given for 14 days for the treatment of MPX.  Patient with non-severe disease will be randomized to tecovirimat vs. blinded control; if disease or pain progress, participants can roll over to the open label treatment. Open label tecovirimat will be given to children, persons with pregnancy, those with severe disease, severe immune suppression, or severe skin conditions.

Email:

[email protected] 

Call/text: (415) 806-8554

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