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

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ClinicalTrials.gov Identifier: NCT00687544
Recruitment Status : Terminated
First Posted : May 30, 2008
Results First Posted : January 30, 2012
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C, Chronic
Hepacivirus
HIV Infections
Interventions Biological: Peginterferon alfa-2b (SCH 054031)
Drug: Ribavirin (SCH 018908)
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Period Title: Overall Study
Started 11
Completed 0
Not Completed 11
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Indonesia Number Analyzed 11 participants
11
1.Primary Outcome
Title Number of Participants Who Achieved Sustained Virologic Response (SVR)
Hide Description

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.

Time Frame Week 48 or Week 72 (depending on duration of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Number of Participants Who Achieved Virologic Response (VR)
Hide Description

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.

Time Frame 24 Weeks or 48 Weeks (depending on duration of treatment, which was either 24 or 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Number of Participants Who Achieved Sustained Biochemical Response (SBR)
Hide Description

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.

Time Frame Week 48 or Week 72 (depending on duration of treatment, which was either 24 or 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants Experiencing Opportunistic Infection
Hide Description The study was terminated due to low enrollment. This analysis was not performed.
Time Frame Throughout the study (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants Who Died
Hide Description [Not Specified]
Time Frame Throughout the study (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
0
6.Secondary Outcome
Title Number of Participants Experiencing Adverse Events
Hide Description 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.
Time Frame Throughout the study (up to 72 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description:
Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description There was one event, "Hypertrophy Concanasalii Sinitra" that could not be coded.
 
Arm/Group Title PEG-IFN + RBV
Hide Arm/Group Description Peginterferon alfa-2b (PEG-IFN) + Ribavirin (RBV) therapy in previously untreated chronic Hepatitis C Virus (HCV) subjects coinfected with Human Immunodeficiency Virus (HIV)
All-Cause Mortality
PEG-IFN + RBV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN + RBV
Affected / at Risk (%)
Total   1/11 (9.09%) 
Blood and lymphatic system disorders   
Anemia  1  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN + RBV
Affected / at Risk (%)
Total   10/11 (90.91%) 
Blood and lymphatic system disorders   
Anemia  1  2/11 (18.18%) 
Ear and labyrinth disorders   
Vertigo  1  1/11 (9.09%) 
Eye disorders   
Asthenopia  1  1/11 (9.09%) 
Gastrointestinal disorders   
Gastritis  1  6/11 (54.55%) 
Diarrhea  1  2/11 (18.18%) 
Abdominal pain upper  1  1/11 (9.09%) 
Nausea  1  1/11 (9.09%) 
General disorders   
Influenza like illness  1  7/11 (63.64%) 
Fatigue  1  1/11 (9.09%) 
Infections and infestations   
Skin infection  1  2/11 (18.18%) 
Upper respiratory tract infection  1  1/11 (9.09%) 
Gastroenteritis  1  1/11 (9.09%) 
Pharyngitis  1  1/11 (9.09%) 
Urinary tract infection  1  1/11 (9.09%) 
Injury, poisoning and procedural complications   
Procedural pain  1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/11 (9.09%) 
Nervous system disorders   
Dizziness  1  2/11 (18.18%) 
Psychiatric disorders   
Depression  1  2/11 (18.18%) 
Anxiety  1  2/11 (18.18%) 
Insomnia  1  2/11 (18.18%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/11 (9.09%) 
Throat irritation  1  1/11 (9.09%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact  1  1/11 (9.09%) 
Pigmentation disorder  1  1/11 (9.09%) 
Dermatitis  1  1/11 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
The study was terminated early due to low enrollment. The primary and secondary outcomes were not evaluated. A formal safety analysis was not performed for the 11 participants enrolled in the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator agrees not to publish/present any interim results without sponsor's prior written consent and agrees to provide sponsor 45 days written notice prior to submission for publication/presentation to permit the sponsor to review copies. The sponsor shall have the right to review and comment, including editing.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00687544     History of Changes
Other Study ID Numbers: P04469
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: September 22, 2011
Results First Posted: January 30, 2012
Last Update Posted: April 6, 2017