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 has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henry Sacks, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00246363
First received: October 27, 2005
Last updated: September 14, 2011
Last verified: September 2011
  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
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • progression of liver damage [ Time Frame: one year after enrollment ] [ Designated as safety issue: No ]
    progression of liver damage


Enrollment: 40
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silymarin
Silymarin
Drug: Silymarin
Silymarin (milk thistle)
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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 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.

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

Additional Information:
No publications provided

Responsible Party: Henry Sacks, MD, PhD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00246363     History of Changes
Other Study ID Numbers: GCO 02-1185, R21NR008860
Study First Received: October 27, 2005
Last Updated: September 14, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014