Clinical trial NCT02605304 (phase 2, status: terminated)
Conditions: hiv-1 infection, hepatitis c
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4, B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: ledipasvir/sofosbuvir, ribavirin
SMILES: CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Reason stopped: 
    the study experienced enrollment difficulties.
  
Eligibility 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