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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
This study is ongoing, but not recruiting participants.
First Received: October 27, 2005   Last Updated: June 20, 2008   History of Changes
Sponsors and Collaborators: Mount Sinai School of Medicine
National Institute of Nursing Research (NINR)
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00246363
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • progression of liver damage

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: January 2007
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246363

Locations
United States, New York
Mount Sinai School of Medcine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Henry Cacks, Ph.D., MD Mount Sinai School of Medicine
  More Information

Additional Information:
No publications provided

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

Keywords provided by Mount Sinai School of Medicine:
HIV
Hepatitis C

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009