Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01040039 |
Recruitment Status
:
Terminated
(Investigator left Rockefeller University)
First Posted
: December 25, 2009
Last Update Posted
: May 17, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
HIV Infections Hepatitis C Virus |
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Group/Cohort |
---|
HCV+HIV+ |
HCV+HIV- |
- Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: one year ]
- Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects [ Time Frame: 1 year ]
- Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Between 18 and 75 years of age.
- Ability to give informed consent.
- Platelets greater than 70,000/mm3.
- Hb at least 9.5 g/dl.
- INR < 1.5.
Exclusion Criteria:
- Decompensated cirrhosis.
- Serious uncontrolled medical illness.
- Ingestion of Aspirin within 72 hours of sigmoidoscopy
- Ingestion of non aspirin NSAIDS within 8 hours of sigmoidoscopy
- Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
- Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Alcohol or drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Medical illness requiring prescribed Aspirin or NSAIDs.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040039
United States, New York | |
Rockefeller University | |
New York, New York, United States, 10065 |
Principal Investigator: | Edgar Charles, MD | Rockefeller University |
Responsible Party: | Rockefeller University |
ClinicalTrials.gov Identifier: | NCT01040039 History of Changes |
Other Study ID Numbers: |
ECH-0675 |
First Posted: | December 25, 2009 Key Record Dates |
Last Update Posted: | May 17, 2013 |
Last Verified: | May 2013 |
Keywords provided by Rockefeller University:
HCV HIV |
Additional relevant MeSH terms:
Hepatitis C HIV Infections Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases |
Digestive System Diseases Lentivirus Infections Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |