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
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ClinicalTrials.gov Identifier: NCT00246363 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Last Update Posted : September 15, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hepatitis C | Drug: Silymarin Drug: Placebo | Phase 1 Phase 2 |
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 that rigidly structured clinical trials comparing dietary supplements, herbal products and other alternative modalities with either placebo or standard of care be conducted in a timely fashion. There is a body of evidence that Silymarin is both well tolerated and efficacious for the treatment of Hepatitis C. In patients co-infected with HIV & HCV, treatment choices are sometimes limited by intolerable toxicities of standard therapies for the treatment of HCV when combined with antiretroviral therapy for treatment of HIV. This study will seek to determine if Silymarin, an herbal product that is widely used, will be well tolerated and effective in slowing progression of liver damage in patients co-infected with HIV & HCV.
The Informed Consent Document contains all the required elements of informed consent as required by 21CFR50. The consent clearly states that this is research, participation is voluntary and that treatment with Silymarin may not be effective. Every effort has been made to outline whatever is known about any side effects. There are very few. All study participants are followed closely, are given their test results which are also shared with primary care providers. The investigators have convened a Data and Safety Monitoring Board and the Mount Sinai IRB has approved and will monitor the study.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Randomized Placebo-Controlled Trial Designed to Determine the Tolerability and Efficacy of Silymarin (Milk Thistle) vs. Placebo for the Treatment of Chronic Hepatitis C in HIV Infected Patients |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Silymarin
Silymarin
|
Drug: Silymarin
Silymarin (milk thistle) |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo |
- progression of liver damage [ Time Frame: one year after enrollment ]progression of liver damage

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246363
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029-6574 |
Principal Investigator: | Henry Sacks, Ph.D., MD | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Henry Sacks, MD, PhD, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT00246363 |
Other Study ID Numbers: |
GCO 02-1185 R21NR008860 ( U.S. NIH Grant/Contract ) |
First Posted: | October 30, 2005 Key Record Dates |
Last Update Posted: | September 15, 2011 |
Last Verified: | September 2011 |
HIV Hepatitis C |
Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Silymarin Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |