Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV

NCT01040039 | Terminated

• 1 other identifier: ECH-0675
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to study gut B cells in HCV+HIV+, HCV+HIV-, HCV-HIV+, and HCV-HIV- volunteers. Volunteers will undergo a screening blood draw and flexible sigmoidoscopy with biopsy.

Conditions

HIV Infections; Hepatitis C Virus

Keywords

HCV; HIV

Outcome Measures

Primary Outcomes (1)

• Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects

  one year

Secondary Outcomes (2)

• Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects

  1 year

• Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects

  1 year

Study Arms (2)

HCV+HIV+

HCV+HIV-

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, mucosal samples

MeSH Terms

Conditions

HIV Infections; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Edgar Charles, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: December 25, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

US (1)