HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study is to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who are taking antiretroviral (ARV) therapy.
Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Participants With HIV-1 Coinfection Receiving Concurrent Antiretroviral Therapy (C_ASCENT)
This study will evaluate the safety, tolerability, and effectiveness of a combination of drugs to treat HCV in adults who are coinfected with HIV and HCV. The three drugs are paritaprevir/ritonavir/ombitasvir (PTV/r/OBT), dasabuvir (DSV), and ribavirin (RBV). RBV will be given to participants with HCV genotype 1a only; participants with HCV genotype 1b will not receive RBV.
This study will enroll HCV genotype 1a or 1b and HIV-1 coinfected participants (HCV treatment-naïve or HCV treatment-experienced) who are on a concurrent integrase inhibitor (INI)-based (raltegravir [RAL] or dolutegravir [DTG]) or protease inhibitor (PI)-based (darunavir [DRV] or atazanavir [ATV]) ART regimen. (The ART regimens will not be provided by the study.) The participants will be assigned to one of four cohorts (Cohorts A, B, C, and D). Participants in Cohorts A and B will be on INI-based ART; participants in Cohorts C and D, on PI-based ART. For each group, the study will proceed in two steps: Step 1: on-HCV treatment and Step 2: post-HCV treatment follow-up. Participants in Cohorts A and C will receive the HCV drugs for 24 weeks; participants in Cohorts B and D, for 12 weeks.
Total study duration will be up to 48 weeks. During Step 1 (on-HCV treatment), all participants will have study visits at Weeks 2, 4, 6, 8, 10, and 12. Participants in Cohorts A and C will have additional Step 1 study visits at Weeks 16, 20, and 24.
All participants will have Step 2 (post-treatment follow-up) study visits 4, 12, and 24 weeks after registration to Step 2. Participants in Cohorts B and D will have an additional Step 2 visit 36 weeks after registration to Step 2.
All study visits will include a brief physical exam and blood collection. Select study visits will include pregnancy testing for participants able to become pregnant, an electrocardiogram (EKG), an IFN gamma-induced protein 10 (IP-10) test, and collection of plasma samples.
Some participants may take part in an optional substudy. Participants in the substudy will attend two study visits at entry/Day 0 and Week 4 for 12-hour intensive pharmacokinetic (PK) sampling.
HIV Infections Interferons Ribavirin Ritonavir
For people ages 18 years to 70 years
Step 1 Inclusion Criteria:
NOTE: Hormone-based contraceptives are NOT considered an acceptable form of contraception for female study participants.
Step 1 Exclusion Criteria:
NOTE: To calculate the Child-Pugh score, refer to the following website:http://www.mdcalc.com/child-pugh-score-for-cirrhosis-mortality
Step 2 Inclusion Criteria:
Step 2 Exclusion Criteria:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02194998.
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