Status:
COMPLETED
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
Lead Sponsor:
Henry Sacks
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
HIV Infections
Hepatitis C
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Patients with many different diseases are requesting information from health care providers, (physicians and nurses) about alternative therapies. The paucity of evidence based information requires tha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00246363
Start Date
January 1 2005
End Date
December 1 2007
Last Update
September 15 2011
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574