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A5329: Interferon-Free Therapy for Chronic Hepatitis C Virus Genotype 1 Infection in Subjects with HIV-1 Co-Infection Receiving Concurrent Antiretroviral Therapy

  • Question: To measure the safety and efficacy of an interferon (IFN)-free HCV therapy for 24 or 12 weeks in subjects with HIV-1 co-infection who are taking protocol-defined antiretroviral treatment (ART)
  • POP: HIV genotype 1a or 1b and HIV-1 co-infected subjects who are naïve to HCV treatment and are on a concurrent raltegravir (RAL)-based or darunavir (DRV)-based ART regimen.  
  • Medication: Among subjects taking a RAL-based ART regimen for HIV-1: 24 (cohort A) or 12 (cohort B) weeks of HCV treatment with HVC direct-acting antiviral (DAA) +ribavirin (RBV) therapy: Drug 1: ABT-450/r/ABT-267 (150/100/25mg; two 75/50/12.5mg fixed-dose combination tablets) orally (PO) once a day (QD) plus Drug 2: ABT-333 (250mg) PO twice per day (BID) plus Drug 3: RBV (1000 or 1200mg weight-based dosed in two divided doses PO BID among subjects taking a DRV-based ART regimen for HIV-1: 24 (cohort C) or 12 (cohort D) weeks of HCV treatment with HCV DAA+RBV therapy: Drug 1: ABT -450/r/ABT -267 (150/100/25mg; two 75/50/12.5mg fixed-dose combination tablets) PO QD plus Drug 2: ABT -333 (250mg) PO BID plus Drug 3: RBV (1000 or 1200 mg weight-based) dosed in two divided doses PO BID
  • Duration: Up to 48 weeks per subject
  • Contact: David Currin, RN 919-966-2624

M14-004  A Randomized, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 (HIV-1) Coinfection (TURQUOISE-I)

M14-004 Optional Pharmacogenetic Sub-study
M14-004 Optional Pharmacogenomic Sub-study

  • Question: Safety and efficacy of investigational drugs in reducing the amount of HCV in blood
  • Population: Adult subjects diagnosed with chronic genotype 1 hepatitis C virus (HCV) infection and human immunodeficiency virus type 1 (HIV-1) and either have not taken medications to treat the HCV infection or  have been previously treated for HCV infection using pegylated interferon (pegIFN) and ribavirin (RBV) therapy and the therapy was not effective. Must have suppressed HIV RNA and currently taking one of the following ARV regimens:  Reyataz/Norvir/Truvada or Isentress/ Truvada.
  • Medication:  Investigational drugs ABT-450, ABT-267 and ABT-333
  • Duration: 60 to 72 weeks including 16-19 study visits to the study clinic
  • Contact:Susan Blevins, ANP - 919-843-8763 or pager (919) 216-9815

HPTN 077: A Phase IIa Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Investigational Injectable HIV Integrase Inhibitor, GSK1265744, in HIV-uninfected Men and Women

  • Question: To evaluate the safety, tolerability, and pharmacokinetics of the investigational injectable HIV integrase inhibitor, GSK1265744
  • Population: HIV uninfected men and women at low to minimal risk for acquiring HIV infection, ages 18 to 65
  • Medication: Investigational injectable HIV integrase inhibitor, GSK1265744 vs placebo
  • Duration: 1.5 years
  • Contact: Becky Straub, RN 919-843-9975 or Miriam Chicurel-Bayard, RN 919-843-9922