HIV InfectionsPhase 1/2NCT00246363
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
A Phase 1/2 study testing Silymarin in people with HIV Infections and Hepatitis C, run by Henry Sacks at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Infections, Hepatitis C
- What is being tested?
- Silymarin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029-6574
About this 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
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.
Read the 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.
- Conditions
- HIV Infections, Hepatitis C
- Being tested
- Silymarin, Placebo
- Keywords
- HIV, Hepatitis C
- Medical subject headings
- HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
Silymarin (milk thistle)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Silymarin | Experimental | Silymarin Receives: Drug: Silymarin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of liver damage
progression of liver damage
Measured: one year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Sacks
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Henry Sacks, Icahn School of Medicine at Mount Sinai
- Investigators
- Henry Sacks, Ph.D., MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246363
- Sponsor's protocol ID
- GCO 02-1185
- Other IDs
- R21NR008860
- Status last verified
- Sep 2011
- First submitted
- 27 Oct 2005
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00246363
- Acronym / sponsor ID
- GCO 02-1185
- Conditions
- HIV Infections, Hepatitis C
- Keywords
- HIV, Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Henry SacksUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silymarin | Experimental | Drug: SilymarinSilymarin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SilymarinSilymarin (milk thistle) | Drug | Silymarin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
progression of liver damage
Time frame: one year after enrollment
progression of liver damage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Sacks, Ph.D., MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Silymarin in people with HIV Infections and Hepatitis C, run by Henry Sacks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression of liver damage (time frame: one year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2011.