12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF

• Status: Terminated
• Trial end date: 2017-03-20
• Target enrollment: 0
• Participant gender: All

Summary

People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if people respond to retreatment with sofosbuvir, after it did not work the first time. There is an important need to understand retreatment options in those instances. This clinical trial was done to study the response to two different regimens, ledipasvir/sofosbuvir and ledipasvir/sofosbuvir with ribavirin, and to see if they are safe and well-tolerated in HCV-infected persons whose previous treatment with sofosbuvir had failed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent

• Documentation of non-cirrhotic or cirrhotic status

• HIV-1 infection

• HIV antiretroviral treatment status (ART), CD4+ T-cell (CD4) count and HIV-1 RNA as follows: (1) not on ART with CD4 count >500 cells/mm^3 within 42 days of study entry, (2) elite controller not on ART with CD4 >200 cells/mm^3 within 42 days of study entry and HIV-1 RNA <500 copies/mL on all measurements within 48 weeks prior to study entry, (3) on a stable protocol-approved ART with CD4 count >200 cells/mm^3 and HIV-1 RNA <50 copies/mL within 42 days of study entry

• HCV GT-1 within 12 months prior to study entry

• Prior virologic treatment failure with SOF-containing regimen (SOF/RBV, SOF/PEG/RBV, and SOF/SIM)

• Body mass index (BMI) ≥18 kg/m^2 within 42 days prior to study entry

• Certain laboratory values obtained within 42 days prior to study entry

• Hemoglobin ≥12.0 g/dL for male, ≥11.0 g/dL for female participants

• Aspartate aminotransferase (AST) (SGOT) and Alanine aminotransferase (ALT) (SGOT) <10 x ULN

• For female participants of reproductive potential, a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL performed at screening and within 48 hours prior to study entry

• Agreement to use at least two reliable forms of contraceptive simultaneously while receiving study treatment and for 6 months afterward

• Intention to comply with the dosing instructions and study schedule of assessments

Exclusion Criteria:

• Receipt of any investigational drug or device within 60 days prior to study entry

• Prior exposure to a DAA other than SOF and SIM

• Chronic liver disease of a non-HCV etiology

• Presence of active or acute AIDS-defining opportunistic infections within 42 days prior to study entry

• Active, serious infection (other than HIV-1 or HCV) requiring parenteral antibiotics, antivirals, or antifungals within 42 days prior to study entry

• Hepatitis B virus (HBV) infection (defined as HBsAg positive) within 42 days prior to study entry

• History of clinically significant hemoglobinopathy

• Chronic current use of systemically administered immunosuppressive agents

• History of solid organ transplantation

• Current or prior history of clinical hepatic decompensation

• History of a gastrointestinal disorder (or postoperative condition) that could interfere with the absorption of the study drug

• History of significant or symptomatic pulmonary disease, cardiac disease, or porphyria that in the opinion of the investigator would interfere with the study

• History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy

• Active drug or alcohol use or dependence

• Use of any prohibited concomitant medications per the LDV/SOF product labeling, within 42 days prior to study entry

• Known hypersensitivity to RBV, SOF, LDV, their metabolites, or formulation excipients or any other contraindication to the use of RBV, SOF or LDV

• Currently receiving zidovudine (ZDV), didanosine (ddI), stavudine (d4T) or tipranavir

• Acute HIV infection defined as the phase immediately following infection during which anti-HIV antibodies are undetectable

• Known hepatocellular carcinoma

• Breastfeeding or pregnancy

• A male participant with a pregnant female partner

• Receipt of colony stimulating agents, including but not limited to erythropoietin, within 42 days prior to study entry