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TerminatedNCT00687544Updated Apr 6, 2017Results posted

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

A Phase 4 interventional study of Peginterferon alfa-2b (SCH 054031) and Ribavirin (SCH 018908) in Hepatitis C, Chronic, Hepacivirus and HIV Infections, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-06.

Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hepatitis C, Chronic
  • Hepacivirus
  • HIV Infections

Keywords

  • HIV
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 11 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    PEG-IFN + RBV

    PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV

    Biological: Peginterferon alfa-2b (SCH 054031) · Drug: Ribavirin (SCH 018908)

Interventions

  • BiologicalPeginterferon 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.

    Also known as: PegIntron

  • DrugRibavirin (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.

    Also known as: Rebetol

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Achieved Sustained Virologic Response (SVR)

    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)

  2. Number of Participants Who Achieved Virologic Response (VR)

    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)

  3. Number of Participants Who Achieved Sustained Biochemical Response (SBR)

    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)

Secondary outcomes

  1. Number of Participants Experiencing Opportunistic Infection

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

    Time frame: Throughout the study (up to 72 weeks)

  2. Number of Participants Who Died

    Time frame: Throughout the study (up to 72 weeks)

  3. Number of Participants Experiencing Adverse Events

    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)

07

Results

Posted Jan 30, 2012
Limitations and caveats
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.

Participant flow

Participant flow — Overall Study
MilestonePEG-IFN + RBV
Started11
Completed0
Not completed11

Outcome measures

PrimaryNumber of Participants Who Achieved Sustained Virologic Response (SVR)

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)

No measurements were reported for this outcome.

PrimaryNumber of Participants Who Achieved Virologic Response (VR)

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)

No measurements were reported for this outcome.

SecondaryNumber of Participants Experiencing Opportunistic Infection

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

Time frame:
Throughout the study (up to 72 weeks)

No measurements were reported for this outcome.

PrimaryNumber of Participants Who Achieved Sustained Biochemical Response (SBR)

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)

No measurements were reported for this outcome.

SecondaryNumber of Participants Who Died
Time frame:
Throughout the study (up to 72 weeks)
Reported as:
Number · participants
Number of Participants Who Died
participantsPEG-IFN + RBV
Number of Participants Who Died0
SecondaryNumber of Participants Experiencing Adverse Events

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)
Reported as:
Number · participants
Number of Participants Experiencing Adverse Events
participantsPEG-IFN + RBV
Number of Participants Experiencing Adverse Events10

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PEG-IFN + RBV—1/11 (9.1%)10/11 (90.9%)
Most frequent serious events
Most frequent serious events
EventPEG-IFN + RBV
AnemiaBlood and lymphatic system disorders1/11
Most frequent other events
Showing 10 of 25
Most frequent other events
EventPEG-IFN + RBV
Influenza like illnessGeneral disorders7/11
GastritisGastrointestinal disorders6/11
AnemiaBlood and lymphatic system disorders2/11
DiarrheaGastrointestinal disorders2/11
Skin infectionInfections and infestations2/11
DizzinessNervous system disorders2/11
DepressionPsychiatric disorders2/11
AnxietyPsychiatric disorders2/11
InsomniaPsychiatric disorders2/11
VertigoEar and labyrinth disorders1/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PEG-IFN + RBV
<=18 years0
Between 18 and 65 years11
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)PEG-IFN + RBV
Female0
Male11
Region of Enrollment
Region of Enrollment(participants)PEG-IFN + RBV
Indonesia11
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00687544
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
May 30, 2008
Start date
Dec 2005
Primary completion
Sep 2008
Completion
Sep 2008
Results posted
Jan 30, 2012
Last update
Apr 6, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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