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Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00687544
First received: May 27, 2008
Last updated: October 31, 2014
Last verified: October 2014

May 27, 2008
October 31, 2014
December 2005
September 2008   (final data collection date for primary outcome measure)
  • Number of Participants Who Achieved Sustained Virologic Response (SVR) [ Time Frame: Week 48 or Week 72 (depending on duration of treatment) ] [ Designated as safety issue: No ]

    Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

    SVR was defined as plasma HCV RNA level below lower level of quanitation at the end of 24 weeks follow-up (week 48 or 72).

    The study was terminated due to low enrollment. This analysis was not performed.

  • Number of Participants Who Achieved Virologic Response (VR) [ Time Frame: 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks) ] [ Designated as safety issue: No ]

    Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

    The study was terminated due to low enrollment. This analysis was not performed.

  • Number of Participants Who Achieved Sustained Biochemical Response (SBR) [ Time Frame: Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks) ] [ Designated as safety issue: No ]

    Treatment duration for genotype 1 participants was 48 weeks. Treatment duration for genotypes 2 & 3 participants who had baseline hepatitis c virus ribonucleic acid [HCV-RNA] <800,000 IU/mL was 24 weeks.

    SBR was defined as the presence of normal alanine aminotransferase (ALT) values at the end of 24 weeks follow-up (week 48 or 72).

    The study was terminated due to low enrollment. This analysis was not performed.

  • Efficacy of PEG-IFN + RBV in previously untreated chronic HCV subjects coinfected with HIV, assessed by rate of virologic response (VR) at the end of treatment. [ Time Frame: Treatment duration of up to 24 weeks or 48 weeks with PEG IFN + RBV; follow-up duration of 24 weeks. Virologic response (VR) determined at the end of treatment. ] [ Designated as safety issue: No ]
  • Efficacy of PEG-IFN + RBV in previously untreated chronic HCV subjects coinfected with HIV, assessed by rates of sustained virologic response (undetectable HCV-RNA) and sustained biochemical response (normal ALT) at the end of the 24-week follow up. [ Time Frame: Treatment duration of up to 24 weeks or 48 weeks with PEG IFN + RBV; follow-up duration of 24 weeks. Sustained virologic response (SVR) and sustained biochemical response (SBR) determined at the end of the 24-week follow-up. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00687544 on ClinicalTrials.gov Archive Site
  • Number of Participants Experiencing Opportunistic Infection [ Time Frame: Throughout the study (up to 72 weeks) ] [ Designated as safety issue: No ]
    The study was terminated due to low enrollment. This analysis was not performed.
  • Number of Participants Who Died [ Time Frame: Throughout the study (up to 72 weeks) ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing Adverse Events [ Time Frame: Throughout the study (up to 72 weeks) ] [ Designated as safety issue: Yes ]
    An adverse event was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, biologic (at any dose), or medical device, which did not necessarily have a causal relationship with the treatment.
Subject morbidity rate caused by opportunistic infection, subject mortality rate in the population, and safety and tolerability of PEG-IFN + RBV in previously untreated chronic HCV subjects coinfected with HIV. [ Time Frame: Treatment duration of up to 24 weeks or 48 weeks with PEG IFN + RBV; follow-up duration of 24 weeks. Adverse events assessed at each visit during the treatment and follow-up periods. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)
Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C Infection in HIV-Infected Persons Not Previously Treated With Interferon

In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis C, Chronic
  • Hepacivirus
  • HIV Infections
  • Biological: Peginterferon alfa-2b (SCH 054031)
    Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL.
    Other Name: PegIntron
  • Drug: Ribavirin (SCH 018908)
    Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is <65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is >85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.
    Other Name: Rebetol
Experimental: PEG-IFN + RBV
PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV
Interventions:
  • Biological: Peginterferon alfa-2b (SCH 054031)
  • Drug: Ribavirin (SCH 018908)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.
  • Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy.
  • Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of normal.
  • Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell) count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required.
  • Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic criteria at the Entry visit.
  • Alpha-fetoprotein value within normal limits obtained within one year prior to entry. Results above the upper limit of normal but <=50 ng/mL require both of the following: Alpha-fetoprotein value <=50 ng/mL obtained within 3 months prior to entry in the study and Ultrasound obtained within 3 months prior to entry in the study or that is negative for evidence of hepatocellular carcinoma.
  • Liver biopsy (optional) within 12 months prior to study entry with a pathology report confirming that the histologic diagnosis is consistent with chronic hepatitis.
  • Women of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
  • Reconfirmation that sexually active males must be practicing acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
  • Subjects must be free of any clinically significant diseases other than hepatitis or HIV infection that would interfere with study evaluations.

Exclusion Criteria:

  • Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.
  • HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis.
  • Participation in any other clinical trial within 30 days of entry to this protocol.
  • Treatment with any investigational drug within 30 days of entry to this protocol.
  • Subjects with organ transplants other than cornea and hair transplant.
  • Any cause for the liver disease based on subject history and biopsy (where applicable) other than chronic hepatitis C, including but not limited to coinfection with hepatitis B virus (HBV); hemochromatosis (iron deposition >2+ in liver parenchyma); alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease.
  • Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
  • Hemoglobinopathies (eg, Thalassemia)
  • Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, and encephalopathy.
  • Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.
  • Significant cardiovascular dysfunction within the past 6 months (eg, angina, congestive heart failure, recent myocardial infarction, severe hypertension, or significant arrhythmia). Subjects with electrocardiogram (ECG) showing clinically significant abnormalities.
  • Poorly controlled diabetes mellitus.
  • Chronic pulmonary disease (eg, chronic obstructive pulmonary disease).
  • Immunologically mediated disease.
  • Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
  • Clinical gout.
  • Clinically significant retinal abnormalities.
  • Alcohol consumption of >20 gr/day.
  • Women who are pregnant or nursing.
  • Subjects who have not observed the designated washout periods for any of the prohibited medications.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00687544
P04469
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP