Treatment of Chronic Hepatitis C Virus During Pregnancy
This study involves evaluating a medication for hepatitis C in pregnant women.
If you are a pregnant woman with chronic hepatitis C and you join the study, you are consenting to enroll yourself and your baby after he/she is born.
Maternal participants will have 7 visits over approximately 7 months. Infant participants have four visits over approximately the first year of life.
(This is not a complete list)
- Must be 18 - 45 years of age
- Chronic HCV infection of at least 6 months
- Singleton pregnancy at 20 + 0 to 30 + 0 weeks’ gestation
- Documented negative Hepatitis B testing for current infection (negative HBsAg test) prior to enrollment
- If living with HIV, must be on antiretroviral therapy
Exclusion Criteria (not a complete list)
- Plans to relocate away from the study site area in the next 16 months and unable/unwilling to return for study visits
- History of cirrhosis
- Known fetal chromosomal abnormality prior to enrollment
Evaluating if an Antiretroviral Therapy Medication Change Can Effect Weight
The purpose of this study is to see whether people living with HIV who gained a significant amount of weight after starting an antiretroviral therapy (ART) could gain less weight, or might lose weight, after an ART regimen switch. The study will also look at whether a switch in antiretroviral therapy leads to differences in how the body stores and uses energy, heart and blood vessel health, and bone health. The study will last for 48 weeks (about 1 year). Following the first visit, you will need to come back to the clinic after about 4, 12, 24, 36, and 48 weeks. Each visit may take up to 3 hours.
• Living with HIV-1 • Be 18 years or older • Currently on an Integrase Inhibitor (INSTI) containing regimen (BIC, DTG or RAL), with > 48 weeks INSTI+TAF/FTC (or TAF/3TC) dosing prior to study entry • Have experienced more than 10% weight gain in the 1-3 years after starting these medications • Have a body mass index (BMI) >27.5 kg/m2 • Have study related tests done • Agree to use contraception/birth control methods if capable of becoming pregnant
Evaluating the Safety and Effectiveness of a Medication Used by Those Who have Sex with Male Partners and Are at Risk for HIV Infection
The purpose of this study is to see if Lenacapavir is safe and effective to use as a pre-exposure prevention in Cisgender Men (CGM), Transgender Women (TGW), Transgender Men (TGM) and Gender Non-binary people (GNB), with a high risk of HIV infection.
• CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection. • HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months • Sexually active with ≥ 1 partner assigned male at birth in the last 12 months and 1 of the following: o Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks o History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks o Use of stimulants with sex in the last 12 weeks
Evaluating the Anti-inflammation Effectiveness of a Medication in Adults with HIV-1 and Cytomegalovirus (CMV)
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).
• 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
Hepatitis C Virus Immunity in Women and Children
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.
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
COVID-19 Determinants of Disease Severity, Perinatal Transmission, and Immune Response to COVID-19 Vaccine
To identify the factors that determine disease severity, immune development, and perinatal transmission in COVID-19 infections.
Inclusion criteria
Cohorts 1: Suspected/Infected Individuals (inpatient or outpatient)
1) All ages
2) Suspected or confirmed COVID-19 infection
3) Parents, guardians or patients over the age of 18 years of age must sign the informed consent; and children older than 9 years of age should sign assent, as required.
Cohort 2: Pregnant Women and/or their Infants*
1) Suspected or confirmed COVID-19 infection AND
2) Pregnant women in any stage of gestation, or within 14 days of a 20+ week gestation delivery; we may enroll mothers alone in situations where they choose for their newborn to not participate OR
3) Infants born to eligible mothers; in situations where the mother does not participate in the study, we may enroll infants born to infected women individually into this cohort
*Pregnant women without suspected or confirmed COVID-19 infection will also be enrolled as a healthy control group and will follow the same visit schedule.
Cohort 3 Vaccinated Children, Adults, Pregnant/Lactating Women and/or their Infants
• Pregnant/lactating women with intent to receive a COVID-19 vaccine; we may enroll mothers alone in situation where they choose for their newborn to not participate OR
• Infants born to eligible mothers; in situations where the mother chooses not to participate in the study, we may enroll their infant separately. OR
• Children/Adults of any age with intent to receive a COVID-19 vaccine
Cohort 4 Healthy Controls
• Anyone without an acute illness at the time of enrollment who agrees to participate in the study.
Exclusion criteria
a) Individuals who refuse participation in the study.
A Study to Evaluate the Safety and Effectiveness of a Dietary Supplement Used in Treating COVID-19
The purpose of this trial is to determine whether a commercially available dietary supplement may decrease the severity of patients with early COVID-19
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
Adults Helping Adults With Immune Diseases
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).
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
Children Helping Children With Immune Diseases
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.
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
A Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals
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.
• 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