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NCT02194998 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT02194998: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02194998 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02194998, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment often does not work well and can cause unwanted side effects. The purpose of this study was to evaluate the safety, tolerability, and effectiveness of IFN-free HCV treatment in HIV/HCV coinfected adults who were taking antiretroviral (ARV) therapy.
Primary Outcome
SVR12 was defined as HCV RNA less than the assay LLOQ (\<15 IU/mL) at 12 weeks post HCV treatment discontinuation. A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method. For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation vi
Interventions
- DRUG Ribavirin (RBV)
- DRUG Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)
- DRUG Dasabuvir (DSV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-09-16 |
| Est. Completion | 2018-11-13 |
| Phase | Phase 2 |
Why NCT02194998 stopped before completion
NCT02194998 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin (RBV) is the first listed.
NCT02194998 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02194998 about?
NCT02194998 is a clinical study titled "Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy". HIV and hepatitis C virus (HCV) infection are diseases that share the same risk factors and routes of transmission. For this reason, many people infected with HIV are also infected with HCV. Interferon (IFN) is a drug used to treat HCV; however, in people coinfected with HIV and HCV, IFN treatment o...
What is the current status of trial NCT02194998?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2015-09-16. Estimated completion is 2018-11-13.
What interventions are being tested in trial NCT02194998?
The interventions under investigation include: Ribavirin (RBV) (DRUG), Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT) (DRUG), Dasabuvir (DSV) (DRUG).
Who is sponsoring clinical trial NCT02194998?
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 NCT02194998's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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