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NCT02220868
Sofosbuvir, Ribavirin, for the Treatment of Chronic Hepatitis C Virus Genotype 1 in HIV-Coinfected Patients Receiving Fixed Dose Co-formulation Emtricitabine/ Tenofovir/Cobicistat/Elvitegravir: A Pilot Study
Phase 4 trial testing Sofosbuvir, Ribavirin, and Stribild in Hepatitis C Infection in 10 participants. Completed in 1 September 2015.
1 August 2015
Quick facts
| Lead sponsor | Saint Michael's Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 July 2014 |
| Primary completion | 1 August 2015 |
| Estimated completion | 1 September 2015 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sofosbuvir, Ribavirin, and Stribild — full drug profile →
Conditions studied
- Hepatitis C Infection — all drugs for Hepatitis C Infection →
- HIV Infection — all drugs for HIV Infection →
Sponsor
Saint Michael's Medical Center
Who can join
Adults 18 to 99, any sex, with Hepatitis C Infection or HIV Infection. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
• SVR,12 defined as undetectable HCV RNA levels for 12 weeks after the completion of therapy
Time frame: 12 weeks post treatment
patients who have achieved non-detectable HCV levels 12 weeks post treatment
Sponsor's own description
The protocol will study the safety and efficacy of using sofosbuvir and ribavirin for the treatment of hepatitis c in patients taking stribild.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02220868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hepatitis C Infection
Currently open trials in the same condition.
- NCT02772003 — DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection · Phase 1 · active not recruiting
Other Saint Michael's Medical Center trials
Trials by the same sponsor.
- NCT04826562 — Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND) · Phase 4 · unknown
- NCT02858050 — Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02220868 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Saint Michael's Medical Center
- Last refreshed: 3 August 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02220868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing