Clinical trial NCT00926614: Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis c
Keywords: GT1
HCV
non responder
relapser
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2009-06-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Stephen A Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References: