Other ID Studies

A5320 Viral Hepatitis C Infection Long-term Cohort Study

  • Question: Observational long-term follow-up study in hepatitis C monoinfected and HCV/HIV-1 coinfected subjects.
  • Population: Men and women who received DAA therapy for HCV as part of a clinical trial within the last 12 months. HCV monoinfected or HCV/HIV-1 coinfected. SVR or non-SVR.
  • Medication: No medication is provided. If participant is non-SVR, they may undergo repeat treatment on another clinical trial or through standard of care while enrolled in A5320
  • Duration: Q6 month visits for 5 years
  • Contact: Erin Hoffman 919-843-0720

Status: On-going / Recruiting

A5327 Sofosbuvir plus Ribavirin Without Interferon for Treatment of Acute HCV in HIV-1 Infected Individuals (SWIFT-C)

  • Question: To evaluate HCV treatment response to SOF and RBV taken for 12 or 8 weeks as assessed by SVR12 in persons with existing HIV-1 infection who are acutely infected with any HCV genotype
  • Population:44 HIV-1 co-infected individuals who have acute HCV infection or reinfection
  • Medication: SOF 400mg daily and weight-based RBV (1000 or 1200mg daily in two divided doses)
  • Duration: 32-26 weeks (8-12 weeks on-treatment followed by 24 weeks of follow-up)
  • Contact: David Currin, RN 919-966-2624 or Pager 919-216-2406

Status: On-going / Recruiting

GS-US-366-1992 - A Phase 3b Randomized, Open-label, Controlled Study of the Efficacy, Safety and Tolerability of 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Subjects who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) prior to LDV/SOF HCV Treatment, the HIV/HCV Co-STARs study (Co-infection treatment with SingleTablet Antiviral Regimens)

  • Question: To evaluate efficacy of LDV/SOF as measured by the proportion of subjects achieving HCV RNA below the lower limit of quantification (LLOQ) 12 weeks after the last dose of LDV/SOF (sustained virology response [SVR12]) and to evaluate the safety and tolerability of switching to E/C/F/TAF or F/R/TAF from the current antiretroviral (ARV) therapy in virologically-suppressed, HIV-1/HCV co-infected subjects;
  • Population: Chronic GT 1 HCV, HIV-coinfected adults who do not have cirrhosis and are HCV cirrhotic subjects must be treatment-naïve. Subjects are on a stable HIV regimen with 2 NRTI + 3rd agent with suppressed HIV RNA
  • Medication: Subjects will be randomized to receive E/C/F/TAF or F/R/TAF for 8 weeks. Subjects will then receive 12 weeks of LDV/SOF and continue their F/TAF-based regimen for 12 weeks after completion of LDV/SOF
  • Duration: 32 weeks 
  • Contact: David Currin, RN 919-966-2624 

Status: On-going / Recruiting

M14-730 A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotype 1 – 6 Infection and Human Immunodeficiency Virus-1 (HIV-1) Co-Infection (EXPEDITION-2)

  • Question: The Primary objectives of this study are to compare the SVR12 rates (12-week sustained virologic response) of 8 or 12 weeks of treatment with ABT-493/ABT-530 combination in HCV genotype 1 - 6 infected subjects with HIV-1 coinfection and to assess the safety of treatment with the combination regimen ABT-493/ABT-530 in HCV genotype 1-6 infected subjects with HIV-1 co-infection with or without cirrhosis.
  • Population: Adults ≥ 18 years, with chronic HCV GT1 -6 infection and HIV-1 co-infection without cirrhosis or with compensated cirrhosis, who are either HCV treatment-naïve or prior treatment-experienced.
  • Medication: 8 o 12 weeks of ABT-493 (an NS3/4A PI)/ABT-530 (an NS5A inhibitor)
  • Duration: 36 weeks 
  • Contact: Donna Pittard, 919-843-6512

Status: On-going / Recruiting