A Clinical Research Study Designed To Determine If Treatment of Hepatitis C With Milk Thistle is More Effective Than No Treatment In Patients Infected With Both HIV And Hepatitis C

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

There is some information available that indicates that Milk Thistle is an effective treatment for liver disease. This study will compare Milk Thistle with a placebo, (a medicine that looks just like Milk Thistle but does not contain any Milk Thistle) to see if people with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C. The study will last one year.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Sacks
• Collaborator: National Institute of Nursing Research (NINR)
• Treatments: Silymarin

Criteria

Inclusion Criteria:

• Men and women 18 years old and older

• Blood tests that are positive for a certain type of Hepatitis C known as

• HIV +

• Blood tests for liver function that indicate that the liver is working - must be obtained within one month of study entry

• CD4 counts and HIV viral loads obtained within one month of study entry

• (CD4 count <100 - eligible if HIV Viral Load <25,000)

• (CD4 >100 - eligible with any HIV Viral Load)

Exclusion Criteria:

• Women who are pregnant & breast-feeding & male partners of pregnant women

• Diagnosis of advanced liver disease

• Chronic liver disease other than Hepatitis C

• HIV related infection within two weeks of study entry

• Having had any organ transplant in the past including bone marrow

• History of mental illness including depression within three months of study entry and attempted suicide or hospitalization for the treatment of mental illness at any time in the past

• Chemotherapy treatment or treatment with steroids or other drugs that affect the immune system within six months of study entry

• Problems with alcohol of illegal drugs within one year of study entry. Patients on methadone will be allowed to enter the study.