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 gonorrhea
- Question: Compare ability of different engineered mutants of Neisseria gonorrhea to cause clinical infection
- Population: Healthy men age 18-35; without history of STIs and HIV negative
- Medication: Inoculation with suspension of Neisseria gonorrhea; treatment with IM ceftriaxone for cure
- Duration: 6 days for inpatient stays (may leave during day); additional visit 1 week post treatment
- Call: Susan Blevins, ANP 919-843-8763 or Chris Evans, ANP 919-843-3759
GEN-003-002 - A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects with Genital HSV-2
- Question: To compare the reduction of viral shedding measure as change from baseline in shedding rate among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant
- Population: HIV negative males and non-pregnant females, 18-50 years of age, with a>1 years history of genital HSV-2 and experiencing between 3 and 9 outbreaks per year
- Medication: 1 of 6 combinations of GEN-003 and Matrix M2 or placebo; dosed at days 1, 22 and 43
- Duration: Subjects will enter a baseline period to collect anogenital swabs for 28 days prior to being randomized to 1 of 6 tx arms or placebo. They will then receive injections at days 1, 22 and 43 and be followed for an additional 12 months w/ intermittent at home swab collection.
- Call: Erin Hoffman 919-843-0720 or Susan Blevins 919-843-8763
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, firstname.lastname@example.org