NCT03235154 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Altice FL, Bruce RD, Lucas GM, Lum PJ, Korthuis PT, Flanigan TP, Cunningham CO, Sullivan LE, Vergara-Rodriguez P, Fiellin DA, Cajina A, Botsko M, Nandi V, Gourevitch MN, Finkelstein R; BHIVES Collaborative
HIV treatment outcomes among HIV-infected, opioid-dependent patients receiving buprenorphine/naloxone treatment within HIV clinical care settings: results from a multisite study. J Acquir Immune Defic Syndr. 2011 Mar 1;56 Suppl 1:S22-32. doi: 10.1097/QAI.0b013e318209751e.
Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, Parish B, Burke T, Pak W, Dunkelberg J, Kistin M, Brown J, Jenkusky S, Komaromy M, Qualls C
Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011 Jun 9;364(23):2199-207. doi: 10.1056/NEJMoa1009370. Epub 2011 Jun 1.
Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, Goldberg DJ, Hellard ME
Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013 Aug;57 Suppl 2:S80-9. doi: 10.1093/cid/cit306. Review.
Robaeys G, Grebely J, Mauss S, Bruggmann P, Moussalli J, De Gottardi A, Swan T, Arain A, Kautz A, Stöver H, Wedemeyer H, Schaefer M, Taylor L, Backmund M, Dalgard O, Prins M, Dore GJ; International Network on Hepatitis in Substance Users
Recommendations for the management of hepatitis C virus infection among people who inject drugs. Clin Infect Dis. 2013 Aug;57 Suppl 2:S129-37. doi: 10.1093/cid/cit302.

Bridging Care to HCV Treatment Among Opiate Dependent Patients on Buprenorphine/Naloxone Maintenance Therapy: A Pilot Study of Treating HCV With Epclusa at a Psychiatrist-staffed Outpatient Addiction Clinic

Details for clinical trial NCT03235154

Clinical trial NCT03235154 - References