Clinical trialNCT01878799CompletedPhase 2Interventional

Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment50HIVHepatitis C

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: \- Present treatment for hepatitis C includes the use of a weekly injection and two different pills. This treatment is associated with serious side effects. Drugs that can be taken by mouth and cure HCV infection without serious side effects would be a great help to the large number of people infected with HCV. GS-7977 and GS-5885 are new medications being developed to treat the hepatitis C virus (HCV) infection. They are still being researched and are not approved by the Food and Drug Administration. They are being developed as treatment for hepatitis C as a single pill taken once a day. Objectives: \- To determine whether a combination of the two study drugs can safely and effectively treat HCV infection in people with HIV infection and who do not have cirrhosis of the liver. Eligibility: \- Individuals who have HIV infection and have liver disease caused by infection with HCV. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be collected. Urine samples will be collected from participants who might become pregnant. If a participant has not had a liver biopsy in the past 3 years, one will be required. * Participants will take one pill daily for 12 weeks. This pill will be a combination of the two study drugs. * Treatment will be monitored with frequent clinic visits and blood tests over a total of 60 weeks.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Shyamasundaran Kottilil, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GS-7977/GS- 5885 FDC

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2013
Primary completion: 30 Sept 2014
Completion: 30 Sept 2014
Last update posted: 15 Sept 2016
Registered enrollment: 50
Registry id: NCT01878799

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.