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 February 2020)

NOW OPEN: Doxycycline post-exposure prophylaxis for MSM & TGW ( living with HIV or taking PrEP)
NOW OPEN: We have a study open for ACUTE HCV : 4 weeks of open label oral therapy (Mavyret)
NOW OPEN: 2 Switch studies: One for people on 1^st or 2^nd HIV regimen, who want to switch to DTG/3TC vs continue current ART and 2^nd switch study from Biktarvy to Doravarine/Islatravir

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, contact our outreach coordinator, Dan Berrner at 415 476 4082 ext. 556.

View a list of open clinical trials below.

Acute/Early Infection

STUDY	BASIC CRITERIA	DESIGN	CONTACT
UCSF Treat Acute Study	Adults with new "recent" HIV diagnosis (last known HIV neg test within last 3-6 months); prior PrEP or PEP ok; already initiated on ART for HIV treatment ok as long as within 1 week of starting ART.	Phase IV open-label trial	[email protected] (415)735-5127; [email protected] (415) 443-5035

Antiretroviral Intensification, Inflammation Reduction, and HIV Eradication

STUDY	BASIC CRITERIA	DESIGN	CONTACT
ACTG 5377 Study to determine how long SAR441236 lasts in the body after a single dose and whether SAR441236 has any effect on the viral reservoir (the amount of HIV that cannot be found by standard clinical tests).	HIV+ patients aged 18-70 HBV negative HCV antibody or viral load negative On ART at least 12 months CD4 > 200 HIV Viral load undetectable Not on ART CD4 > 350 HIV Viral load at least 5000 HIV Viral load not more than 100,000 Willingness to start HIV medications by or on day 28 of the study	54-60 participants, randomized 24 to 72 week study Multiple cohorts, increasing doses Intensive design / multiple visits All participants will receive infusion on Day 0. Most participants will have multiple visits from Day 0 to week 24. Some participants will receive additional infusion at weeks 12, 24, and 36. These individuals will have multiple visits from Day 0 to week 72. Study staff will review individual schedules with participants	Dan Berrner Call/text: (415) 535-9495
ACTG 5359 A study looking to see if HIV vaccine is safe in people infected with HIV and whether or not the HIV vaccine improves the immune system’s ability to fight HIV.	HIV+ patients aged 18-65 On ART at least 24 months, no changes CD4 > 500 / lowest CD4 ever > 350 HIV viral load undetectable 36 months HBV negative HCV antibody or viral load negative No use any of HIV vaccine in past year	40 participants, randomized to HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) or placebo 48 weeks Vaccine: Day 0, weeks 4, 12, & 24 Additional visits include: Pre-entry, weeks 6, 26, 48	Dan Berrner Call/text: (415) 535-9495
DARE (Delaney AIDS Research Enterprise to cure HIV)	HIV+ able to undergo leukapheresis large blood draws and/or tissue biopsies. Acute or chronically treated, ART-suppressed >12 months or elite/viremic controllers (VL<2000 while not taking ART). Other criteria apply. Compensation provided.	A group of studies learning how & where HIV persists in the body. Multiple visits to measure HIV viral reservoirs via blood draws, leukapheresis, and tissue biopsies.	Call 415-476-4082, x139, or x104; email [email protected] or [email protected]
EMRLHD (Effect of Methamphetamine on Residual Latent HIV Disease) Study	HIV+ adults who use methamphetamine (smoke, IV, etc.) in a "binge" pattern (e.g., some months frequently each week and other months once or twice), ART suppressed at least 2 years, and current CD4>350, HIV VL<40, and not on protease inhibitor regimen. No contraindications for getting inguinal lymph node fine needle aspirate. Hair on head at least 2 inches long.	Cohort study. Longitudinal fine needle aspirate collections of inguinal lymph nodes, spaced approximately 6 months apart for a total of 3 lymph node collections.	[email protected] (415)735-5127; [email protected] (415) 476-4082 ext. 139; [email protected] (415) 476-4082 ext. 155; [email protected] (415) 476-4082
EMRLHD (Effect of Methamphetamine on Residual Latent HIV Disease) Study	HIV+ adults with ART suppression at 2 years (no ART regimen change in prior 1 year), NO PRIOR history of meth dependence (ok if prior Adderall or Dexedrine for treatment of ADHD as long as over 1 year ago), no cardiac history, no hx of psychosis.	Phase I trial. Participants will be admininstered a total of 25 mg of oral methamphetamine in the Clinical Research Services Center.	[email protected] (415)735-5127; [email protected] (415) 476-4082 ext. 139; [email protected] (415) 476-4082 ext. 155
IDEO (Inflammation, Diabetes, Multi-Ethnic Obesity Cohort)	Enrolling HIV(+) & HIV(-), age 25-65 who do not currently have diabetes or active hepatitis. Other criteria apply. Compensation provided.	A study seeking to learn about body composition and metabolic complications in HIV across different ethnic groups. 4-6 visits for measurements of muscle, fat, and bone, and metabolic.	Call 415-476-4082, ext. 340; [email protected].
PENNVAX	HIV+ age 18-65, ART-suppressed >24 months, CD4>350 and CD4 nadir >200. Excellent venous access in both arms. Other criteria apply. Compensation provided	Evaluating safety, immunogenicity and anti-reservoir activity of a therapeutic HIV DNA vaccine vs placebo. Involves 1-2 screening visits, 2 leukaphereses, 4 vaccinations with electroporesis over 4 months, and follow-up blood draws over 12 months. No treatment interruptions are involved.	Call 415-476-4082 x139; [email protected].

Complications, Co-Infection, and Prevention of STDs

STUDY	BASIC CRITERIA	DESIGN	CONTACT
I AM OLD (Inflammation, Aging, Microbes and Obstructive Lung Disease)	HIV+, willing and able to undergo pulmonary function testing (PFTs), answer questions, and provide blood	Prospective, observational cohort study of HIV-associated chronic obstructive pulmonary disease (COPD)	Amanda Jan: 415-206-2485
DoxyPEP	Men who have sex with men or a transgender women living with HIV or taking/starting HIV PreP, with a history of gonorrhea, chlamydia or syphilis in the past year	Participants will be randomized 2:1 to receive open label doxycycline or continued standard of care for 12 months of follow-up.	Call (415) 939 4535 if you are living with HIV & enrolled at ZSFG) or (415) 855-0402 (PrEP patients, enrolled at SF City clinic

Viral Hepatitis

STUDY	BASIC CRITERIA	DESIGN	CONTACT
ACTG 5380 Acute HCV treatment with 4 weeks of glecaprevir/pibrentasvir (HIV (+) or HIV uninfected)	Individuals with acute HCV	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 5368 PD-1 inhibitor in individuals with chronic HBV on suppressive HBV antiviral therapy (HBV-monoinfection only	Adults with chronic HBV infection. HIV co-infection is exclusionary.	Adults with chronic HBV infection (HBV surface antigen positive) who have HBV DNA suppression on oral nucleot(s)ide therapy will receive infusion of open label PD-1 inhibitor (cemiplimab) at two time points. Participants are required to undergo a study provide liver biopsy twice during the study.	Dan Berrner Call/text: (415) 535-9495

STUDY

BASIC CRITERIA

DESIGN

CONTACT

ACTG 5380

Acute HCV treatment with 4 weeks of glecaprevir/pibrentasvir (HIV (+) or HIV uninfected)

Individuals with acute HCV

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 5368

PD-1 inhibitor in individuals with chronic HBV on suppressive HBV antiviral therapy (HBV-monoinfection only

Adults with chronic HBV infection.

HIV co-infection is exclusionary.

Adults with chronic HBV infection (HBV surface antigen positive) who have HBV DNA suppression on oral nucleot(s)ide therapy will receive infusion of open label PD-1 inhibitor (cemiplimab) at two time points. Participants are required to undergo a study provide liver biopsy twice during the study.

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

HIV Treatment

STUDY	BASIC CRITERIA	DESIGN	CONTACT
ACTG 5357 Injectable Cabotegravir with Neutralizing Monoclonal Antibody) infusion.	HIV+ patients age 18 and older On ART at least 8 weeks, no changes CD4 > 350 HIV viral load undetectable 24 months HBV negative HCV antibody or viral load negative Good veins in at least one arm	Phase II study injectable cabotegravir given every 4 weeks along with an infusion of a broadly neutralizing monoclonal antibodies (bNABS) every 8 weeks for 36 weeks. Participants will first be transitioned to oral cabotegravir/NRTIs for 4 weeks to ensure tolerance. Eligibility includes HIV suppression on ART for at least 2 years	Dan Berrner Call/text: (415) 535-9495
ACTG 5369 Injectable cabotegravir + rilpivirine for individuals who have been non-adherent to oral ART	HIV+ patients aged 18-65 On ART at least 24 months, no changes CD4 > 500 / lowest CD4 ever > 350 HIV viral load undetectable 36 months HBV negative HCV antibody or viral load negative No use any of HIV vaccine in past year	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.	Dan Berrner Call/text: (415) 535-9495
Switch to dolutegravir/3TC	HIV+ on 1st or 2nd ART regimen (INSTI/PI/NNRTI + 2 NRTI) and are virologically suppressed for	Phase III study of DTG/3TC. Participants will be randomized 1:1 to open label, fixed dose DTG/3TC vs. continued current ART. Previous changes from TDF->TAF, ritonavir-> cobicistat, 3TC->FTC do not count as regimen changes. INSTI and major NRTI mutations are exclusionary.	Dan Berrner Call/text: (415) 535-9495

STUDY

BASIC CRITERIA

DESIGN

CONTACT

ACTG 5357

Injectable Cabotegravir with Neutralizing Monoclonal Antibody) infusion.

HIV+ patients age 18 and older
On ART at least 8 weeks, no changes
CD4 > 350
HIV viral load undetectable 24 months
HBV negative
HCV antibody or viral load negative
Good veins in at least one arm

Phase II study injectable cabotegravir given every 4 weeks along with an infusion of a broadly neutralizing monoclonal antibodies (bNABS) every 8 weeks for 36 weeks. Participants will first be transitioned to oral cabotegravir/NRTIs for 4 weeks to ensure tolerance.

Eligibility includes HIV suppression on ART for at least 2 years

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

ACTG 5369

Injectable cabotegravir + rilpivirine for individuals who have been non-adherent to oral ART

HIV+ patients aged 18-65
On ART at least 24 months, no changes
CD4 > 500 / lowest CD4 ever > 350
HIV viral load undetectable 36 months
HBV negative
HCV antibody or viral load negative
No use any of HIV vaccine in past year

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.

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

Switch to dolutegravir/3TC

HIV+ on 1st or 2nd ART regimen (INSTI/PI/NNRTI + 2 NRTI) and are virologically suppressed for

Phase III study of DTG/3TC. Participants will be randomized 1:1 to open label, fixed dose DTG/3TC vs. continued current ART. Previous changes from TDF->TAF, ritonavir-> cobicistat, 3TC->FTC do not count as regimen changes. INSTI and major NRTI mutations are exclusionary.

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

Immunologic

STUDY	BASIC CRITERIA	DESIGN	CONTACT

Observational and Other

STUDY	BASIC CRITERIA	DESIGN	CONTACT
FNA (Fine Needle Aspiration)	HIV+, able to undergo FNA. Enrolling either 1) newly infected or 2) ART-suppressed > 6 months, or 3) elite/viremic controllers (VL<2000 not on ART. Other criteria apply. Compensation provided.	Involves 1-2 visits including 2-hour visit for FNA of inguinal lymph nodes using guided ultraound and performed under local anesthetic. Lymph node aspirates will support multiple projects focused on viral reservoirs mechanisms of persistance and inflammation.	Call 415-476-4082, ext. 144; [email protected].
GALT (Gut Associated Lymphoid Tissue) Study	HIV+, willing/able to do flex sigs or colonoscopies. Enrolling acute or chronically treated & ART-suppressed > 12 months or ) elite/viremic controllers (VL<2000 not on ART). Other criteria apply. Compensation provided.	Flexible sigmoidoscopy or colonoscopy performed by Ma Somsouk at ZSFGH GI Center. Research colonoscopy provides full cancer screen (same as a clinical colonoscopy). Tissue biopsies will support multiple projects focused on viral reservoirs mechanisms of persistance and inflammation.	Call 415-476-4082 x140; [email protected]
HIPSTER (HIV Imaging: PET/MRI Scans To Evaluate Reservoirs	Acute, Early or late infected individuals, Viremic individuals also required	PET-MR Imaging of HIV infection and immune activation	Tim Henrich 415-206-5518 or 415-476-4082, ext. 340; [email protected].
Leukapheresis	HIV+ with excellent venous access in both arms and able to sit still for up to 3 hours. Enrolling 1) ART-suppressed > 12 months or 2) elite/viremic controllers (VL<2000 not on ART). Other criteria apply. Compensation provided.	Involves 2 visits including a screening visit and a 3-4 hour leukapheresis (white blood cell) collection. Lymph node aspirates will support multiple projects focused on viral reservoirs mechanisms of persistance and inflammation.	Call 415-476-4082 x139 or x 104; [email protected]; [email protected]
SCOPE Study	Observational study recruiting 1) elite or viral controllers with VL<2000copies/mL & not taking ART, 2) ART-suppressed >12 months, or 3) individuals not taking ART with high viral loads.	Interviews & blood draws 2-3 times per year. Compensation provided.	Call 415-476-4082 x140 or x 155; email [email protected] or [email protected].
SCOPE (Shingrix observation)	Any HIV infected individuals on ART	To ernoll in SCOPE if planning to receive Shingrix vaccine for routine clinical care (not for research study) We will collect blood prior to and 48 hours post vaccine	415-206-5518 (Henrich)