NCT00246363

Brief 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 improvement or cure of Hepatitis C. The study will last one year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Jan 2005

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 15, 2011

Status Verified

September 1, 2011

Enrollment Period

2.9 years

First QC Date

October 27, 2005

Last Update Submit

September 14, 2011

Conditions

HIV InfectionsHepatitis C

Keywords

HIVHepatitis C

Outcome Measures

Primary Outcomes (1)

  • progression of liver damage

    progression of liver damage

    one year after enrollment

Study Arms (2)

Silymarin

EXPERIMENTAL

Silymarin

Drug: Silymarin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SilymarinDRUG

Silymarin (milk thistle)

Silymarin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatitis C

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis, Viral, HumanFlaviviridae InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

FlavonolignansFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Henry Sacks, Ph.D., MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 27, 2005

First Posted

October 31, 2005

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 15, 2011

Record last verified: 2011-09

Locations

US(1)