Infectious Disease

Official Title

A5383, Randomized, Controlled Trial to Evaluate the Antiinflammatory Efficacy of Letermovir (Prevymis) in Adults with Human Immunodeficiency Virus (HIV)-1 and Asymptomatic Cytomegalovirus (CMV) Who Are on Suppressive ART and Its Effect on Chronic Inflammation, HIV Persistence, and Other Clinical Outcomes (ELICIT)

Purpose

The purpose of this study is to evaluate whether letermovir (Prevymis), taken as two 240 mg tablets (480 mg total) or one 480 mg tablet once daily for 48 weeks, reduces inflammation in adults with human immunodeficiency virus (HIV-1) who also have cytomegalovirus (CMV) without any symptoms and who have been on effective anti-HIV medication for at least one year. Reducing inflammation might in turn help prevent some longer-term consequences of HIV, like heart disease and diabetes. This study will also look at whether you experience any side effects to the study drug. The study will last for about 1 year and 2 months (about 11 months on either letermovir or no anti-CMV study reatment and then about another 3 months of follow-up).

Could this study be right for you?

• HIV and CMV antibody positive •greater than or equal to 40 years of age • Not currently using any of the following ART medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice daily OK) • Not pregnant or breastfeeding or planning to become pregnant during the study • No use of anti-CMV drugs within 90 days prior to study participation • No active HCV or HBV in past 24 weeks No presence or history of atrial or ventricular tachycardias • All gender identities are eligible, but there are enrollment targets for cis-women or transgender women on gender-affirming hormones

Age Range

40 and up

Official Title

Hepatitis C Virus Immunity in Women and Children

Purpose

This is a study to find out how pregnancy affects a mother’s immune system. (The “immune system” is the part of the body that fights germs.) This study is also to find out why some babies who are exposed to infections during pregnancy get infected and others do not.

To do this project we need to study some women and babies who are infected with the hepatitis C virus and others who are not. This will allow us to compare their immune systems.

Could this study be right for you?

You may be eligible to participate if you are:

PREGNANCY COHORT eligibility criteria:
1) Pregnant (enrollment preferably during 1st or 2nd trimester, but may occur as late as the delivery hospitalization)
2) HCV-RNA positive (#150) or HCV-RNA negative (#50)
3) Willing and able to attend all study visits

Exclusion criteria for mothers:
1) Inability to provide informed consent
2) Incarceration

Inclusion criteria for infants:
1) Child born to study mother

Exclusion criteria for infants:
1) In custody of county children’s services (Enrolled infants who are temporarily in custody of children’s services will not have further study blood draws, but lab results from blood tests ordered by their pediatrician may be followed to monitor the outcome of their HCV exposure. Infants who are later placed back in the custody of their mother or relative may be re-enrolled.)

NON-PREGNANCY COHORT eligibility criteria:
1) Willing and able to attend all study visits

Exclusion criteria:
1) Currently pregnant
2) Inability to provide informed consent
3) Incarceration

Official Title

Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of a Plant Polyphenol for COVID-19

Purpose

The purpose of this trial is to determine whether a commercially available dietary supplement may decrease the severity of patients with early COVID-19

Could this study be right for you?

Inclusion Criteria:

- Outpatients who test positive for infection with SARS-CoV-2
- Age 45 years and older
- Experiencing COVID 19 symptoms for 7 days or less,
OR 72 hours of new respiratory symptoms
- Patient must have access to the internet or a smartphone to complete surveys
- English-speaking patients

Age Range

45 and up

Official Title

Creation of a pediatric healthy control repository for clinical diagnostic immunology test development and validation

Purpose

A test for healthy adults from 19 - 75 years old to develop normal values for interpretation of immunological tests in adults with disorders of the immune system.

Voluntary participation involves blood draw at Nationwide Children's hospital. Qualified participants would be eligible to provide a sample every 2 months (not more than 6 times per year).

Could this study be right for you?

If you are:

- An adult 19 years of age or older
- Healthy with no significant medical diagnoses
- Have no chronic conditions that can affect results of immunological studies
- Not any medication known to alter immune status or function
- Have not undergone recent surgery, chemotherapy, radiation or transplantation
- Non-smoker
- Body mass index (BMI) in healthy range
- No infections within last 2 months

Age Range

19 and up

Official Title

Creation of a pediatric healthy control repository for clinical diagnostic immunology test development and validation

Purpose

This study uses healthy children from newborns to 18 years old to help understand immune disorders. This study will compare healthy children and teens to children and teens with disorders of the immune system.

Volunteers will visit Nationwide Children's Hospital (NCH) for a blood draw either one time or not more than once every three months.

Could this study be right for you?

If your child is:

- Newborn to 18 years of age
- Healthy with no significant medical diagnoses
- Has no chronic medical conditions that can affect results of immunological studies
- Is not on any medication known to alter immune status or function
- Has not undergone recent surgery, chemotherapy, radiation or transplantation
- Has had no infections within the last 2 months

Official Title

A5359; A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals

Purpose

This study is investigating if Long-Acting (LA) Injectable HIV-medications will be more successful for people who are non-adherent to their HIV medications than oral standard of care regimens. To be eligible to receive LA ART, participants will need to attain virologic suppression through adherence to an oral regimen first.

Could this study be right for you?

• Be between 18 - 75 years of age
• Previously 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
• Evidence of non-adherence to previous HIV medications

Age Range

18 and up

Official Title

A PILOT, PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, STUDY TO EVALUATE EFFICACY, SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND PHARMACOGENETICS OF CC-220 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Purpose

The purpose of this study is to test the effects of a new drug called CC-22. Researchers want to find out if it does or does not improve the symptoms of those diagnosed with Systemic Lupus Erythematosus (SLE).

Could this study be right for you?

You may be eligible for this study if:
You have been diagnosed with SLE
You have had SLE longer than (or equal to) six (6) months
You have three (3) or more tender joints at the baseline visit
You have skin manifestations of Lupus

Age Range

18 and up