Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

Completed · Phase 3

Conditions studied: Hepatitis C, Human Immunodeficiency Virus

In brief

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Key facts

Study ID

NCT01667731

Run by

Gilead Sciences

People needed

224

Starts

2012-07-01

Expected to finish

2014-02-01

Last updated by the study team

2014-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide written informed consent
• Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
• HCV RNA > 1 x 10\^4 IU/mL at screening
• Infection with HCV genotype 1, 2 or 3 as determined at screening
• HIV-1 infection confirmed with positive ELISA or Western blot at screening
• Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
• Confirmation of chronic HCV infection
• Ability to determine presence/absence of cirrhosis.
• HIV antiretroviral therapy (ARV) criteria of one of the following:
• ARV untreated with a CD4 T-cell count > 500 cells/mm\^3
• On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm\^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
• Approved HIV antiretroviral medications based on drug interaction studies
• Not been treated with any investigational drug or device within 30 days of the screening visit
• Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
• Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
• Must be of generally good health as determined by the investigator.
• Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

You may not qualify if…

• Non-genotype 1/2/3 or mixed genotype at screening
• Genotype 1 with prior treatment for HCV
• Poor control with ARV regimen
• Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
• Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
• A new AIDS-defining condition diagnosed within 30 days prior to screening
• Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
• Infection with hepatitis B virus (HBV)
• Contraindication to RBV therapy
• Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)
• History of solid organ transplantation or malignancy diagnosed or treated within 5 years
• Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Coronado, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lutherville, California, United States
• Study site — Oakland, California, United States
• Study site — Sacramento, California, United States
• Study site — San Francisco, California, United States
• Study site — Torrance, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Providence, Rhode Island, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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