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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Infections, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00246363

Run by

Henry Sacks

People needed

40

Starts

2005-01-01

Expected to finish

2007-12-01

Last updated by the study team

2011-09-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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