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

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

DMID09-0106: Experimental Human Infection with Isogenic Mutants of Neisseria gonorrea 

  • Question: Compare ability of different engineered mutants of Neisseria gonorrea to cause clinical infection
  • Population: Healthy men age 18-35; without history of STIs and HIV negative
  • Medication: Inoculation with suspension of Neisseria gonorrea; treatment with IM ceftriaxone for cure
  • Duration: 6 days for inpatient stays (may leave during day); additional visit 1 week post treatment
  • Call: Amanda Crooks (919) 843-9564 or (919) 428-7612

GS-US-334-0115: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects with Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

  • Question: The purpose of this study is to look at the safety and efficacy of a 12week course of Sofosbuvir/Ledipasvir in volunteers with Chronic Genotype 1 or 4 HCV and HIV-1 infection.
  • Population: 300 volunteers (5 at UNC) Chronic Genotype 1 or 4 HCV and HIV-1 co-infected, male and non-pregnant/non-lactating females, ages 18 or older. 20% may have compensated cirrhosis. 
  • Medication:Fixed dose Sofosbuvir/ Ledipasvir
  • Duration: 12 Weeks of treatment. In the Retreatment sub-study, volunteers will receive HCV treatment for 24 weeks.
  • Contact: David Currin, RN 919-966-2624 or Pager 919-216-2406

I-CAN Study Incentivizing HCV Treatment Adherence in Mono- and Co-Infected Patients

  • Question: To learn more about ways to improve how people take their HCV medications, including the use of rewards for taking these medications and coming to clinic appointments.
  • POP: Men & women have HCV or HCV/HIV and are HCV treatment naïve who will be prescribed a 12 week HCV regimen and who have past or current hx of substance abuse.
  • MED: none provided by the study
  • DUR: 12 weeks
  • CALL: Becky Straub, 919-843-9975, bstraub@med.unc.edu