Open Clinical Studies | HIV, ID and Global Medicine

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 September 2023)

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.

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

For non-COVID studies, you can contact us at (415) 535-9495 or [email protected]
For COVID studies you can contact us at (415) 806-8554 or [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 with a LOW risk for disease progression. Participants must have tested positive for COVID ≤ 3 days from study enrollment, and their symptoms must have begun ≤3 days from enrollment. You may qualify if you: 1. Are between the ages of 18-64 years old. 2. Are still experiencing at least one COVID system within 24 hours of enrollment. 3. Have not yet received any COVID treatment since testing positive. 4. Have a low risk of getting very sick from COVID or having to be hospitalized for COVID-related symptoms. You are not considered low risk if you have obesity, diabetes, high blood pressure, or a compromised immune system.	OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2d/SCORPIO-HR) This study will look at an experimental 3-day oral treatment for recent COVID infection to see if it can reduce the severity and duration of COVID symptoms. Other standard of care COVID treatments—including oral/inhaled/intravenous therapies—are allowed after enrollment if there are no drug interactions with the study drug. Paxlovid is prohibited due to drug interactions. Your vaccination status does not affect your eligibility. Safe transportation will be provided for patients during the infectious time period.	Email: [email protected] Please call/text (415) 806-8554 (English/Spanish)

STUDY

BASIC ELIGIBILITY CRITERIA

DESIGN

CONTACT

ACTIV-2d/SCORPIO-HR

The study will enroll patients with a LOW risk for disease progression. Participants must have tested positive for COVID ≤ 3 days from study enrollment, and their symptoms must have begun ≤3 days from enrollment. You may qualify if you:

1. Are between the ages of 18-64 years old.

2. Are still experiencing at least one COVID system within 24 hours of enrollment.

3. Have not yet received any COVID treatment since testing positive.

4. Have a low risk of getting very sick from COVID or having to be hospitalized for COVID-related symptoms. You are not considered low risk if you have obesity, diabetes, high blood pressure, or a compromised immune system.

OUTPATIENT TREATMENT FOR RECENT COVID INFECTION (ACTIV-2d/SCORPIO-HR)

This study will look at an experimental 3-day oral treatment for recent COVID infection to see if it can reduce the severity and duration of COVID symptoms. Other standard of care COVID treatments—including oral/inhaled/intravenous therapies—are allowed after enrollment if there are no drug interactions with the study drug. Paxlovid is prohibited due to drug interactions.

Your vaccination status does not affect your eligibility. Safe transportation will be provided for patients during the infectious time period.

Email:

[email protected]

Please call/text (415) 806-8554 (English/Spanish)

Studies for People Living With HIV

STUDY	BASIC ELIGIBILITY CRITERIA	DESIGN	CONTACT
The DO-IT Study, A5391	Eligibility includes BMI ≥ 30 kg/m², ART regimen with an integrase inhibitor (bictegravir, raltegravir, dolutegravir), and suppressed HIV VL for at least 48 weeks. Note: Eligibility has been revised to remove the requirement for unintentional weight gain of > 10% in the 1-3 years	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.	Email: [email protected] 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.	Email: [email protected] 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.	NJECTABLE 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) 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.	Email: [email protected] Call/text: (415) 535-9495
ELICIT, A5383	Eligible participants are 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.	Email: [email protected] Call/text: (415) 535-9495
A5355	Eligible participants are 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.	Email: [email protected] Call/text: (415) 535-9495
A5415	1. Living with HIV and be 45 years of age or older. 2. Be on continuous HIV treatment for the last 48 weeks with undetectable HIV viral load in the last 48 weeks. 3. On NNRTI-based or unboosted INSTI-based ART regimen. 4. Have no active heart or blood vessel disease or be at increased risk for heart disease. 5. Not pregnant or breastfeeding.	A LIMITED-CENTER, PROSPECTIVE, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTS OF CENICRIVIROC MESYLATE ON ARTERIAL INFLAMMATION IN PEOPLE LIVING WITH HIV Phase 2 trial randomizing participants living with HIV 2:1 to the addition of entry inhibitor cenicriviroc versus placebo, stratified by current statin use versus no statin use, for 24 weeks to compare effects on arterial inflammation as measured by baseline and end-of-study PET-CT of the aorta and metabolic parameters, inflammatory markers, and hematologic activation markers. Eligibility criteria include age > 45 years, on stable NNRTI- or unboosted INSTI-based ART, and suppressed HIV-1 RNA for > 48 weeks with at least one cardiovascular risk factor.	Email: [email protected] Call/text: (415) 535-9495

STUDY

BASIC ELIGIBILITY CRITERIA

DESIGN

CONTACT

The DO-IT Study, A5391

Eligibility includes BMI ≥ 30 kg/m², ART regimen with an integrase inhibitor (bictegravir, raltegravir, dolutegravir), and suppressed HIV VL for at least 48 weeks.

Note: Eligibility has been revised to remove the requirement for unintentional weight gain of > 10% in the 1-3 years

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.

Email:

[email protected]

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.

Email:

[email protected]

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.

NJECTABLE 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) 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.

Email:

[email protected]

Call/text: (415) 535-9495

ELICIT, A5383

Eligible participants are 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.

Email:

[email protected]

Call/text: (415) 535-9495

A5355

Eligible participants are 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.

Email:

[email protected]

Call/text: (415) 535-9495

A5415

1. Living with HIV and be 45 years of age or older.

2. Be on continuous HIV treatment for the last 48 weeks with undetectable HIV viral load in the last 48 weeks.

3. On NNRTI-based or unboosted INSTI-based ART regimen.

4. Have no active heart or blood vessel disease or be at increased risk for heart disease.

5. Not pregnant or breastfeeding.

A LIMITED-CENTER, PROSPECTIVE, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTS OF CENICRIVIROC MESYLATE ON ARTERIAL INFLAMMATION IN PEOPLE LIVING WITH HIV

Phase 2 trial randomizing participants living with HIV 2:1 to the addition of entry inhibitor cenicriviroc versus placebo, stratified by current statin use versus no statin use, for 24 weeks to compare effects on arterial inflammation as measured by baseline and end-of-study PET-CT of the aorta and metabolic parameters, inflammatory markers, and hematologic activation markers. Eligibility criteria include age > 45 years, on stable NNRTI- or unboosted INSTI-based ART, and suppressed HIV-1 RNA for > 48 weeks with at least one cardiovascular risk factor.

Email:

[email protected]

Call/text: (415) 535-9495

Viral Hepatitis Studies

STUDY	BASIC CRITERIA	DESIGN	CONTACT
A5394	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.	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

STUDY

BASIC CRITERIA

DESIGN

CONTACT

A5394

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.

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

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	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	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	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	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