deltatrials
Terminated PHASE4 INTERVENTIONAL NCT00194857

Treatment of Anemia and Neutropenia in HIV/HCV Coinfected Patients Treated With Pegylated Interferon and Ribavirin

A Randomized Clinical Trial Comparing Two Management Strategies for Treatment of Neutropenia and Anemia Associated With Pegylated Interferon Plus Ribavirin Treatment of Compensated Chronic Hepatitis C in Adult Subjects Infected With HIV.

Sponsor: Schering-Plough

Updated 6 times since 2017 Last updated: Dec 14, 2012 Started: Feb 28, 2002 Primary completion: Dec 31, 2005 Completion: Dec 31, 2005
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

A PHASE4 clinical study on Anemia and HIV Infections, this trial is terminated or withdrawn. The trial is conducted by Schering-Plough and has accumulated 6 data snapshots since 2002. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.

This is a multi-center, randomized, open-labeled trial in subjects co-infected with hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1) who are naïve to anti-HCV therapy. Subjects will receive PEG interferon alfa-2b (PEG-IFN) 1.5 mcg/kg/week administered once weekly plus ribavirin (RBV) 13 + 2 mg/kg/day. The goal of this study is to evaluate two different treatment options for anemia and neutropenia associated with the initiation of pegylated interferon and ribavirin. This will result in completion of therapy, and possibly a better viral sustained response.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated~Jan 2026 – present · 3 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Present [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

Show 1 earlier version
  1. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE4

    First recorded

Feb 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Schering-Plough
  • Weill Medical College of Cornell University
Data source: Weill Medical College of Cornell University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations