studies

Full Title: “A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to Chronically Infected HCV Treatment Naïve Populations Globally: The MINMON Study”

Scientists are looking at ways to simplify Hepatitis C (HCV) treatment. This study will include people who are infected with HCV without decompensated cirrhosis (a condition where the liver is damaged and does not work well), regardless of HIV-1 co-infection (both with or without HIV infection will be accepted; either on ART [experienced] or not having started treatment [naïve]); and never have used treatment for Hepatitis C.

Purpose of this Study: This study is trying to find out if minimal or less tests during treatment for Hepatitis C can be done safely  compared to the current standard monitoring tests (according to recent data and current practices for standard HCV monitoring). Participants will receive the fixed-dose combination (single tablet) of Sofosbuvir/Velpatasvir (SOF/VEL) for 12 weeks.

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

• Not having been previously treated for Hepatitis C infection with any medications.
• Be willing to take drugs to treat HCV right away.
• Have certain tests done that will be explained to you by the study coordinator
• Agree to use contraception/birth control methods.
• Be 18 years old or older.
• Be willing to sign the consent after talking with the research staff.

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

• Positive for the presence of Hepatitis B Virus.
• 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.
• Any history of other hepatic illnesses other than HCV.

Talk to your study staff for a complete list of inclusion/exclusion criteria.

Treatment:

• Fixed-dose combination of SOF/VEL single-tablet regimen for 12 weeks.

Procedures:

• Blood tests at clinic visits to check mainly liver and kidney function.
• Telephone calls or text messaging for some study time points.
• Adherence monitoring.

Duration of Study: 72 weeks. 12 weeks on study treatment, followed by follow-up visits at weeks 24, 48 and 72.

Will evaluate whether starting antiretroviral drugs very early in HIV infection will limit the virus from getting into hidden areas of the body (reservoirs) and change how the immune system helps to control the virus.

Study Description
This study will include people who have very recently been infected with HIV and will start anti-HIV (antiretroviral) drugs right away to see how this may change HIV’s impact on the body.

Why is this study being done?
This study is trying to find out if starting antiretroviral drugs very early in HIV infection will change the following:

• Limit the virus from getting into hidden areas of the body (“reservoirs”).
• Change how the immune system helps to control the virus.

What we mean by very early is even before the blood shows that antibodies have been made, or just at the time antibodies are starting to be found in the blood.

Who can join?
Men and women who:

• Are at least 18 years old
• Have had certain lab tests done that confirm very early HIV infection
• Are willing to take antiretroviral drugs right away to treat HIV.

What do I need to do in the study?
Participants will start elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) single-tablet regimen (often called “Genvoya”) within 24 hours but no later than 48 hours after entering the study.

Blood tests will be done at all clinic visits to check HIV blood levels and immune cells.

Some participants may be approached to take part in additional optional procedures later in the study to check out the “reservoirs” where the virus might hide:

• Leukapheresis or large volume blood collection
• Lumbar puncture (cerebrospinal fluid) (also called a “spinal tap”)
• Gut biopsy (also called “sigmoidoscopy with biopsy”)

The duration of the study is up to 72 weeks (a year and a half).

What treatments or drugs are involved with this study?
The study treatment that will be provided through the study is EVG/COBI/FTC/TAF single-tablet regimen. Other antiretroviral drugs are allowed if EVG/COBI/FTC/TAF is not the ideal drug for a particular person.