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

NCT00926614 | Completed Phase 4

• 1 other identifier: C.2008.153
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis c

Keywords

GT1; HCV; non responder; relapser

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pioglitizone and Atorvastatin

EXPERIMENTAL

Pioglitazone and Atorvastatin added to standard of care Pegasys and weight based ribavirin

Drug: pioglitazone (Actos); Drug: atorvastatin (Lipitor)

Interventions

pioglitazone (Actos) DRUG

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

Also known as: Actos

Pioglitizone and Atorvastatin

atorvastatin (Lipitor) DRUG

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

Also known as: Lipitor

Pioglitizone and Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Pioglitazone; Atorvastatin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Stephen A Harrison, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 23, 2009
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 14, 2012

Record last verified: 2012-02

Locations

US (1)