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Sponsors and Collaborators: |
Mount Sinai School of Medicine National Institute of Nursing Research (NINR) |
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Information provided by: | Mount Sinai School of Medicine |
ClinicalTrials.gov Identifier: | NCT00246363 |
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.
Condition | Intervention | Phase |
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HIV Infections Hepatitis C |
Drug: Silymarin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2007 |
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 antiretrovital 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Mount Sinai School of Medcine | |
New York, New York, United States, 10029-6574 |
Principal Investigator: | Henry Cacks, Ph.D., MD | Mount Sinai School of Medicine |
Study ID Numbers: | R21 NR008860, GCO # 02-1185 |
Study First Received: | October 27, 2005 |
Last Updated: | June 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00246363 History of Changes |
Health Authority: | United States: Institutional Review Board |
HIV Hepatitis C |
Sexually Transmitted Diseases, Viral Liver Diseases Antioxidants Hepatitis, Chronic Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Immunologic Deficiency Syndromes Hepatitis Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Silymarin Hepatitis C Hepatitis C, Chronic Retroviridae Infections Milk Thistle |
Liver Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Antioxidants Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Hepatitis, Viral, Human Infection |
Protective Agents Pharmacologic Actions Immunologic Deficiency Syndromes Hepatitis Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Silymarin Hepatitis C Retroviridae Infections |