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NCT01878799 · ClinicalTrials.gov registry record · Phase 2
Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01878799: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01878799 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01878799, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary end point was sustained virologic response \[plasma HCV RNA level \<12 IU/mL by real-time HCV assay (Abbott)\] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.
Interventions
- DRUG GS-7977/GS- 5885 FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01878799 record still lists
NCT01878799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which GS-7977/GS- 5885 FDC is the first listed.
NCT01878799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01878799 about?
NCT01878799 is a clinical study titled "Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV". 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 ...
What is the current status of trial NCT01878799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01878799?
The interventions under investigation include: GS-7977/GS- 5885 FDC (DRUG).
Who is sponsoring clinical trial NCT01878799?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01878799's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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