HIV Infections Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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