HIV InfectionsNCT01040039
Pilot Study to Assess Gut Mucosal B Cells in Individuals With HCV and HIV
An observational study of HIV Infections and Hepatitis C Virus, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Hepatitis C Virus
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Sep 2011
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV
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.
Read the detailed description
Hepatitis C virus (HCV) infects approximately 170 million people worldwide and is the leading indication of liver transplantation in the United States. HCV is primarily a blood-borne infection, and heterosexual transmission is rare. However, acute HCV infection is increasingly being reported among HIV-positive men who have sex with men (MSM) with no risk factors for parenteral HCV transmission, suggestive of a possible mucosal route of infection in these individuals. While it is possible that HCV may be transmitted into the bloodstream via mucosal tears induced by sexual activity, is also possible that a mucosal immune defect predisposes HIV+ persons to mucosal HCV transmission. Our 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. We will isolate peripheral and mucosal mononuclear cells and we will perform HCV-specific ELISPOT and single B cell immunoglobulin (Ig) RT-PCR to assess volunteers' gut B cell repertoire. If successful, we would like to expand the study so as to better assess Ig repertoire differences among HCV+HIV+ and HCV+HIV- individuals.
- Conditions
- HIV Infections, Hepatitis C Virus
- Keywords
- HCV, HIV
- 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.
| Study group | Role | What they receive |
|---|---|---|
| HCV+HIV+ | Not described | |
| HCV+HIV- | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
Measured: one year
Secondary outcomes (2)
Numbers of HCV-specific gut mucosal B cells in HCV-HIV+ and HCV-HIV- subjects
Measured: 1 year
Distribution of gut mucosal B cell Ig gene segment usage in HCV+HIV+, compared to HCV+HIV- subjects
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Investigator left Rockefeller University
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edgar Charles, MD, Principal investigator, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040039
- Sponsor's protocol ID
- ECH-0675
- Status last verified
- May 2013
- First submitted
- 19 Nov 2009
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Gut Mucosal B Cells in Individuals Co-Infected With HCV and HIV
- ClinicalTrials.gov ID
- NCT01040039
- Acronym / sponsor ID
- ECH-0675
- Conditions
- HIV Infections, Hepatitis C Virus
- Keywords
- HCV, HIV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left Rockefeller University
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Dec 2009 (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.
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.
Detailed description
Hepatitis C virus (HCV) infects approximately 170 million people worldwide and is the leading indication of liver transplantation in the United States. HCV is primarily a blood-borne infection, and heterosexual transmission is rare. However, acute HCV infection is increasingly being reported among HIV-positive men who have sex with men (MSM) with no risk factors for parenteral HCV transmission, suggestive of a possible mucosal route of infection in these individuals. While it is possible that HCV may be transmitted into the bloodstream via mucosal tears induced by sexual activity, is also possible that a mucosal immune defect predisposes HIV+ persons to mucosal HCV transmission. Our 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. We will isolate peripheral and mucosal mononuclear cells and we will perform HCV-specific ELISPOT and single B cell immunoglobulin (Ig) RT-PCR to assess volunteers' gut B cell repertoire. If successful, we would like to expand the study so as to better assess Ig repertoire differences among HCV+HIV+ and HCV+HIV- individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV+HIV+ | – | – |
| HCV+HIV- | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects
Time frame: one year
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Investigator left Rockefeller University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
Related trials for HIV Infections
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
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.
Edgar Charles, MD principal investigator
Rockefeller University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Hepatitis C Virus, run by Rockefeller University 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 5 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: stopped early, as of the sponsor's last update on 17 May 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left Rockefeller University). Results are not available in the source record.
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?
Numbers of HCV-specific gut mucosal B cells in HCV+HIV+, compared to HCV+HIV- subjects (time frame: one year). 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 17 May 2013.