Problems With Immune Recovery in the Gut Tissue | NCT01460433

Studies
Problems With Immune Recovery in the Gut Tissue

NCT01460433

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Sep 5, 2014Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Human Immunodeficiency Virus

Interventions

Genital and rectal swabbing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P01AI074340	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Oct 24, 2011

First Submission Date that Met QC Criteria

Oct 24, 2011

First Posted Date

Oct 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2014

Last Update Posted Date

Sep 5, 2014Estimated

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genital and rectal swabbing	Procedure	Subjects swabs their genitals and rectum daily. The amount of HSV shed over the previous 24 hours is measured and the daily HSV shed rate is calculated.

Measure	Description	Time Frame
Herpes Simplex Virus - Type 2 shed rate		60 days

Measure	Description	Time Frame
Evidence of HIV replication in blood and lymphoid tissue		60 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV+ individuals

Seropositive for HIV
On ART for at least 12 months
Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
Age ≥ 18 years
Negative pregnancy test for eligible women of childbearing potential

HIV- individuals

Seronegative for HIV
Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
Age ≥ 18 years
Negative pregnancy test for eligible women of childbearing potential

Exclusion Criteria:

Taking daily suppressive therapy for Herpes Simplex Type 2
Contraindication to surgical & endoscopic procedures (as judged by PI)
Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV+, antiretroviral-treated individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus and HIV- individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Schacker, MD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Condition Browse Module

MeSH Terms

ID	Term
D000163	Acquired Immunodeficiency Syndrome

Ancestor Terms

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided