studies

Brief Description:
This study will include 180 participants. Participants will have HIV and Cytomegalovirus (CMV). CMV is common virus that many people living with and without HIV have been exposed to. You do not need to know if you have CMV to be considered for study participation. About half of the study participants will be given study medication to be taken once daily for 48 weeks. The study medication will be letermovir, an FDA approved medication to prevent CMV. The other half of
participants will not receive any additional medication. The study will last about 1 year and 2 months.
Purpose of this Study:
To learn whether people living with well controlled HIV and symptom free CMV can reduce inflammation by taking a drug approved by the FDA to prevent CMV disease.
To Enter the Study, the following must be true about you:

• HIV positive, ≥40 years of age
• On continuous anti-HIV medications for at least 48 months with no interruptions >7 days
• At least 48 months of undetectable viral loads, although a one-time, low-level viral load is OK
• Have not made significant change in HIV medication in the past 12 weeks, or plan to make changes during study participation
• No heart arrythmias/ irregular heart beats
• No active Hepatitis B or hepatitis C within 24 weeks
• Not currently using any of the following HIV medications: efavirenz, nevirapine, etravirine, lopinavir/ritonavir, or once a day dosing of raltegravir (twice a day dosing is OK)
• While people with any CD4 count are eligible, the study is particularly interested in recruiting people with low CD4 counts (i.e., <350 cells/mm3)
• While people of all gender identities are eligible, the study is particularly interested in recruiting cis-gender women and transgender women receiving gender-affirming hormones

Treatment:
There will be treatment provided in this study. Letermovir is a pill given by mouth once a day that is FDA-approved to prevent CMV disease. There are two study treatment groups.
You will have a 50/50 chance of going into one of the two groups. Participants in one group will get letermovir and participants in the other group will not get any additional medications.

“Safety and Immunotherapeutic Activity of Cemiplimab in Participants with HBV on Suppressive Antiviral Therapy: A Phase I/II Ascending Multiple Dose Study”

Brief Description: Scientists are looking at ways to cure Hepatitis B (HBV). This study will assess the safety and tolerability of cemiplimab administered in participants with HBV on suppressive antiviral therapy.

Purpose of this Study: This study is trying to find out if cemiplimab is safe and well tolerated. Participants will receive multiple dose levels (0.3, 1.0, and 3.0 mg/kg) of cemiplimab administered as two infusions at weeks 6 and 12.

Requirements to Enter Study (things that must be true for you):

• Have chronic HBV infection (defined as HBsAg positive) and under treatment for ≥12 months with tenofovir- or entecavir-containing therapy: tenofovir disoproxil fumarate (TDF), tenofovir alanfenamide (TAF), TDF/emtricitabine (FTC), TAF/FTC, or entecavir.
• Be willing to continue HBV antiviral therapy throughout the study.
• Have certain tests done.
• Agree to use contraception/birth control methods.
• Be 18 years old or older but less than 70 years.
• Weight ≥40 kg.
• Had evidence of limited or no evidence of fibrosis (F0-F2) by liver biopsy or noninvasive alternative method.
• Be willing to sign the consent after discussion with the research staff.

Exclusion Criteria (things that cannot be true about you):

• Positive for the presence of Hepatitis C Virus.
• Received investigational drug or device within 60 days prior to study entry.
• Breastfeeding or pregnancy.
• Known allergy/sensitivity or any hypersensitivity to components of study drug(s).
• Active drug or alcohol use or dependence and other conditions that would interfere with adherence to study.
• Acute or serious illness requiring systemic treatment and/or hospitalization within 35 days prior to study entry.
• History of immunoglobulin IgG therapy or interferon (IFN) therapy within 12 months prior to study entry.
• A male participant with a pregnant female partner.
• Any vaccination within 30 days prior to entry.

Treatment:

• Multiple dose levels (0.3, 1.0 and 3.0 mg/kg) of cemiplimab administered as two infusions at weeks 6 and 12.

Procedures:

• Blood tests at clinic visits to check mainly hepatic and renal function.
• Liver biopsy at study entry and at week 18 on study.
• Leukapheresis for a group of participants.

Duration of Study: Participants will be on study for up to 90 weeks (78 weeks following the last study drug infusion) with frequent safety evaluations.