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 September 2020

  • NOW OPEN:  Injectable cabotegravir+rilpivirine for individuals who have been non-adherent to oral ART (A5359)

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.

For COVID-related studies, please contact Veronica Viar at (415) 806-8554.

View a list of open clinical trials below.

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

Adults 18 and over who tested positive for COVID-19 (not more than 7 days ago) and are at home with newly diagnosed COVID.

You must have at least 1 of the symptoms below within the last two days: fever, sore throat, chills, body pain or muscle aches, headache, tiredness, headache, trouble breathing or cough

Please visit https://www.activ-2.org/en/ (English) or https://www.activ-2.org/es/ (Spanish) for more information

Phase 2/3 platform trial of treatments Providing a single infusion of monoclonal antibodies vs.  placebo for people with a diagnosis of COVID and symptom onset of less than 10 days.  Safe transportation will be provided for patients during the isolation time period. Call or text Veronica Viar at (415) 806-8554 (English/Spanish)

*Coming soon*

COVID Vaccine Studies

For more information, please visit: https://www.coronaviruspreventionnetwork.org/    

 

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
The LATITUDE Study

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.

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

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
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

*Coming Soon*

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

*Coming Soon*

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

*Coming Soon*

Several studies evaluating HBV cure strategies in HBV mono-infected individuals on suppressive NRTI therapy.

  More information forthcoming  
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
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)