Current and Upcoming Studies



A5395: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons with COVID-19

The primary objective of the study is to evaluateif hydroxychloroquine (HCQ) and azithromycin (Azithro) treatment will prevent hospitalizations and death in adults with COVID-19.

Key Requirements to Enter the Study

  • 18 years of age or older
  • Positive test of the nose or throat for COVID-19 from any respiratory specimen collected within 96 hours prior to when the first dose of study treatment is expected to be taken
  • Experiencing at least one of the following symptoms: fever, cough, or shortness of breath
  • Agreement to not participate in another COVID-19 study during the study period or take HCQ or Azithro from a source outside of the study. If a participant is hospitalized during the study, they can participate in another COVID-19 study


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Regeneron 6R88-COV-2040 - An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients with COVID-19

The primary objective of the study is to evaluate the clinical efficacy of sarilumab, a monoclonal antibody IL-6 receptor antagonist, relative to the control arm in adult patients hospitalized with severe or critical COVID-19. Participants are randomized in a 2:2:1 ratio to sarilumab 400 mg IV, 200 mg IV, or placebo.

 

Requirements to Enter Study:

  • Confirmed SARS-Cov-2 infection
  • P≥18 years.
  • Hospitalized (or documentation of a plan to admit to the hospital if the patient is in an emergency department)
  • Evidence of pneumonia by chest radiograph, chest computed tomography or chest auscultation (rales, crackles)
  • Fever documented in the medical record
  •  Requires supplemental oxygen administration by nasal cannula, simple face mask, non-rebreather mask or high-flow nasal cannula, invasive or non-invasive ventilation OR requiring treatment in an intensive care unit OR multiorgan system dysfunction
  • No known or suspected active bacterial, fungal or mycobacterial infections
  • ANC ≥ 2000/mm3, AST and ALT ≤ 5 x ULN, platelets ≥ 50,000/mm3


A5359: Long-Acting Antiretroviral Therapy in Non-adherent Persons living with HIV (PLWH)

This study is investigating if Long-Acting Injectable ART will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. The main advantages of LA ART in this population include infrequent dosing and directly observed therapy. A challenge for participants is that, to be eligible to receive LA ART, they will need to attain virologic suppression through adherence to their standard of care oral medications. Financial incentives will be used during the first 20 weeks of the study to motivate participants to be adherent to an oral regimen until they are eligible to be randomized to either the LA ART arm or the standard of care arm.

 

Requirements to Enter Study:

  • PLWH who are 18 years of age or older.
  • Prescribed ART for at least 6 months.
  • Screening HIV RNA is greater than 200 copies.
  • Women must not be pregnant, planning to become pregnant, or breastfeeding. Women who can become pregnant must agree to use 1 form of effective birth control.
  • There is evidence of non-adherence to their HIV medications. Non-adherence to HIV medications will be defined as having one of the two criteria below:

1. Poor virologic response within the last 18 months (defined as <1 log10 decrease in HIV-1 RNA from the participant’s historical baseline value or HIV-1 RNA >200 copies/mL at two time points at least 4 weeks apart) in individuals who have been prescribed ART for at least 6 consecutive months.

 

        2. Lost to clinical follow-up within the last 18 months with ART non-adherence for ≥6 consecutive months. Lost to clinical follow-up is defined as either no contact with provider or missed 2 or more appointments in a 6-month period. ART non-adherence is defined as a lapse in ART ≥7 days (consecutive or non-consecutive), in the 6-month period where they were lost to clinical follow-up per participant report.


 


A5371: A Single-Arm, Open-Label, Pilot study of Semaglutide for Non-Alcoholic Fatty Liver Disease (NAFLD), a Metabolic Syndrome with Insulin Resistance, Increased Hepatic Lipids, an Increased Cardiovascular Disease Risk (The SLIM LIVER Study)

Is                                   Is a single-arm, open-label, pilot study of the effects of semiglutide on intra-hepatic triglyceride (IHTG) content in adults with HIV and hepatic steatosis, central adiposity, and insulin resistance. IHTG will be quantified by estimation of the IHTG using magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at two time points. Participants will also complete food diaries, adherence and strength assessments, and report on physical activity. Stool and blood samples will be collected at several visits

Requirements to Enter Study:


  • 18 years of age or older
  • Living with HIV Virologically suppressed
  • Currently on ART for at least 24 weeks

 

A5379: B-Enhancement HBV Vaccination in persons Living with HIV (Bee-HIVe): Evaluation of Heplisav-B 

This study will evaluate a two- and three-dose regimen of HEPLISAV-B, each compared to a standard three-dose regimen of ENGERIX-B in HBV vaccine-experienced participants with anti-HBs <10 mIU/mL (Group A). It will also evaluate adults living with HIV with no known prior history of HBV vaccination (Group B) vaccinated with HEPLISAV-B.

Requirements to Enter Study:

  • Individuals living with HIV at least 18 years old
  • On current ART for more than 56 days
  • CD4 >100 within 180 days of entry
  • HIV-1 RNA < 1000 copies within 180 days of entry

        A5380: Glecaprevir/pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus            Infection (PURGE-C)

This study will evaluate acute HCV treatment response to G/P given for 4 weeks as assessed by sustained virologic response 12 weeks post-treatment (SVR12, defined as HCV RNA <lower limit of quantification, target detected or target not detected).

The study will also evaluate the safety and tolerability of combination oral antiviral therapy with G/P given for 4 weeks in persons with acute HCV-infection, regardless of genotype and HIV status.

 

Requirements to Enter Study:

  • Age 18 years of age
  • Mono or Co-infected
  • Documentation of acute HCV infection
  • If HIV positive, ARV untreated due to lack of indication per provider or on a stable antiretroviral regimen
  • If HIV positive, HIV RNA <50 and CD4 >100, if on ART
  • Must agree not to participate in a conception process
  • HCV treatment naïve during current acute HCV infection
  • Non-cirrhotic with no other chronic liver disease
  • Hepatitis A and B negative
  • Not pregnant or breastfeeding

 

The relationship between the gut microbiome composition and pulmonary immune function in HIV infection 

This study will characterize the relationship between gut microbes and their metabolites and immune phenotype and function of AM and T cells in the lung of HIV-infected individuals and HIV-negative controls using an integrated multi’omic approach. Particular gut microbiome compositions and their products/metabolites, will be associated with suppressed activation of pathogen response pathways and phagocytic activity of lung AMs and regulatory phenotypes of both AMs and T cell populations.

Requirements to Enter Study:

     ·         Men and women; 18 years to 70 years (All Cohorts)

·         Subjects with chronic HIV-1 Infection defined as a positive ELISA confirmed by a positive Western Blot or plasma      HIV-1 RNA level >1,000 copies/mL at any time in the past. (Cohorts A)

·         HIV-1 seronegative (Cohorts B & C)

·         Exhibits high-risk MSM behavior as determined with the risk behavior questionnaire (Cohort B)

·         Does not have high-risk MSM behavior as determined with the risk behavior questionnaire (Cohort C)

·         Body mass index (BMI) between 21-29 mg/kg2 and weight stable for at least 3 months (All Cohorts)

·         Long-term ART (Cohort A): Must be on stable three-drug ART regimen for a minimum of 12 months prior to Visit 1.

 

ANCHOR Study: Anal Cancer/HSIL Outcomes Research Study

The purpose of this study is to determine whether screening and treatments of precancerous areas of the anus can prevent anal cancer. The lesions that cause anal cancer (high-grade squamous intraepithelial lesions or HSIL) are found in at least half of HIV infected men and 20% of HIV infected women. These lesions have no symptoms. Anal cancer is more common in HIV+ people than in the general population. If caught early, anal cancer is much more easily treated and with fewer side effects. 

Requirements to Enter Study:

  • ​HIV+ men and women
  • 35 years of age or older
  • Never been vaccinated against HPV (human papillomavirus)
  • You have HSIL
  • Never been treated for anal HSIL
  • Never have had cancer of the anus, vulva, vagina, or cervix​​

Diet Modification Study: Diet/Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients  

This study plans to learn more about the short-term effects of consuming either a Western-style diet or an Agrarian-style diet (a diet low in fat and high in fiber/carbohydrates) on inflammatory and metabolic markers in people with and without HIV. The study will consist of 4 clinic visits which will include a physical exam and blood collection at each visit. At entry, participants will be asked to answer two dietary questionnaires and will be randomized to a 2-week supplied diet (Agrarian vs. Western). Visit 3 will supply each participant with dietary counseling and recipes to continue study diet for the following two weeks. All participants will be asked to donate 3 stool samples. Participants have the option to undergo a flexible sigmoidoscopy/mucosal biopsy at visits 2 and 4.

Requirements to Enter Study:

  • HIV-positive and negative men and women between the ages of 18 and 65  
  • BMI between 21-29 kg/m2 (non-obese)
  • If HIV-positive, treated with ART for at least 12 months with no changes in ARVs over the past 6 months
  • If HIV-positive, plasma HIV-1 RNA ≤50 copies/mL in preceding 6 months       

 

HIV Disability Questionnaire HDQ 

This study is trying to establish if a short-form version of the HDQ adequately captures the health related challenges or disabilities that patients living with HIV have on the day-to-day bases in the same way that the longer version does.