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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00381017
Other study ID # P04371
Secondary ID EUDRACT NUMBER:2
Status Withdrawn
Phase Phase 3
First received September 26, 2006
Last updated August 11, 2014
Start date September 2006

Study information

Verified date August 2014
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a Phase 3b, randomized, open-label, parallel-group, multi-center, multi-national study of low-dose maintenance Peg interferon alpha-2b (Peg-Intron®) in subjects with human immunodeficiency virus-hepatitis C virus (HIV-HCV) co-infection. The primary objective is to compare at end of study the efficacy of Peg-Intron® monotherapy (0.5 µg/kg subcutaneously once weekly for 24-36 months) versus standard supportive care, using the time to any of the following clinical events (death, decompensation, liver transplant, hepatocellular carcinoma [HCC]) as endpoints.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

- Age at least 18 years but < 70 years, of either sex or any race.

- Detectable plasma hepatitis C virus (HCV) RNA (all genotypes of HCV are permitted).

- Cirrhosis of the liver within the last five years.

- Compensated liver disease (Child-Pugh <8 with hepatic encephalopathy <= 1.

- No evidence of hepatocellular carcinoma (HCC) and a serum alpha fetoprotein (AFP) <100 ng/mL within two months of randomization/study enrollment.

- Varices results via endoscopy within the last six months or at time of screening.

- Serologic evidence of human immunodeficiency virus-1.

- CD4 cell count >=100 /µL.

- Platelet number of at least 50000 mm**3.

- Neutrophil count of at least 750 mm**3.

- Hemoglobin of >9.0 mg%.

- Serum thyroid stimulating hormone levels within normal limits, regardless of treatment with L thyroxin.

- Hemoglobin A1c (HbA1c)<8.5%, to demonstrate controlled diabetes, if applicable.

- Written clearance from an ophthalmologist must be presented for subjects with a history of hypertension or diabetes prior to treatment start.

- Creatinine clearance >50 mL/min, as assessed by the indirect calculation method.

- Demonstrate stable status of HIV-1 infection.

- On stable antiretroviral therapy (HAART) for at least 6 weeks prior to baseline, with the expectation of their HAART regimen (drugs and dosage) remaining unaltered for the first 8 weeks of the study OR

- Willing to delay initiation of HAART therapy for at least 6 weeks (for subjects who have not been on HAART for at least 8 weeks prior to randomization). "Structured treatment interruptions" will be permitted during the study.

- Counseled in the appropriate use of birth control while in this study, as confirmed by the principal investigator or a sub-investigator.

- Free of any clinically significant disease (other than HCV and HIV) that would interfere with study evaluations.

Exclusion Criteria:

- Female who is pregnant, intends to become pregnant during the study or within two months after study completion, or is nursing. Male subject whose partner wants to become pregnant.

- Using silymarin.

- Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or HBeAg.

- Any cause of liver disease other than chronic hepatitis C.

- Suspected or having hypersensitivity to interferon.

- History of liver decompensation status or other evidence of bleeding from esophageal varices, signs of current bleeding, significant ascites, hepatic encephalopathy, jaundice or other conditions consistent with decompensated liver disease.

- Present with a lesion suspicious for hepatic malignancy on the screening imaging.

- Any active malignant disease, suspicion, or history of malignant disease within 5 years prior to study enrollment (except for adequately treated basal cell carcinoma).

- Known coagulation or hemoglobin diseases.

- Organ transplant, except corneal or hair transplant.

- Any known preexisting medical condition that, in the investigator's opinion, could interfere with the subject's participation in and completion of the study, such as major depressive disorder.

- Active HIV-related opportunistic infection and/or malignancy requiring systemic therapy.

- Evidence of known severe retinopathy.

- Subject has not observed the designated washout periods for any of the prohibited medications.

- Participating in any other hepatitis C clinical study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Peg interferon alpha-2b


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp. Integrated Therapeutics Group
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