Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

48 Week Pilot Trial Assessing the Efficacy of Pioglitazone, Atorvastatin, Pegasys and Weight Based Ribavirin in Chronic Hepatitis C, Genotype 1 Patients Who Have Previously Relapsed or Did Not Respond to PegInterferon /Ribavirin Therapy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00926614

Enrollment

Registered

2009-06-23

Start date

2008-09-30

Completion date

2011-12-31

Last updated

2012-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis c

Keywords

GT1, HCV, non responder, relapser

Brief summary

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

Detailed description

The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin. This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Interventions

DRUGpioglitazone (Actos)

pioglitazone 30 mg qd for 30 days, then increase to 45 mg

DRUGatorvastatin (Lipitor)

atorvastatin 40 mg for 30 days then increase to 80 mg daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* GT 1 previously treated with pegylated interferon & ribavirin & either non-responded or relapsed after cessation of therapy * Insulin resistance * Compensated liver disease * WBC \< 3,000/ mm3 * Neutrophil count \< 1,500/mm3 * Platelets \< 65,000/ mm3 * Albumin \> 3 gm/dL

Exclusion criteria

* Participants on metformin or other thiazolidinedione must have 3month wash-out period * Women who are pregnant or breast-feeding * Males with pregnant partners * Co-infection with HAV, HBV, or HIV * Ophthalmic abnormalities such as severe retinopathy * Poorly controlled thyroid dysfunction * Serum creatinine concentration \> 1.5 times ULN * Severe psychiatric or neuropsychiatric disorders * History of alcoholism or drug addiction 1 year prior to screening * Seizure disorders not controlled with medication * Significant cardiovascular dysfunction within the past 12 months * Chronic pulmonary disease

Design outcomes

Primary

Measure	Time frame
Improvement is seen in insulin resistance patients to be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.	36 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026