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Problems With Immune Recovery in the Gut Tissue

This study is currently recruiting participants.
Verified August 2012 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01460433
First received: October 24, 2011
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus
 Procedure: Genital and rectal swabbing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Herpes Simplex Virus - Type 2 shed rate [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: September 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Genital and rectal swabbing
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

HIV+ individuals

  • Seropositive for HIV
  • On ART for at least 12 months
  • Seropositive to HSV2 and CMV
  • Age ≥ 18 years
  • Negative pregnancy test for eligible women of childbearing potential

HIV- individuals

  • Seronegative for HIV
  • Seropositive for HSV2 and CMV
  • Age ≥ 18 years
  • Negative pregnancy test for eligible women of childbearing potential

Exclusion Criteria:

  • Taking daily suppressive therapy for HSV2
  • Contraindication to surgical & endoscopic procedures (as judged by PI)
  • Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460433

Contacts
Contact: Ann Seguin, RN 612-625-7472 segu0017@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ann Seguin, RN     612-625-7472     segu0017@umn.edu    
Principal Investigator: Timothy Schacker, MD            
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Timothy Schacker, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01460433     History of Changes
Other Study ID Numbers: 0712M22449, P01AI074340
Study First Received: October 24, 2011
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV 1
HSV 2
Treatment experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013