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Problems With Immune Recovery in the Gut Tissue

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460433
First Posted: October 26, 2011
Last Update Posted: September 5, 2014
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.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: 60 days ]

Biospecimen Retention:   Samples Without DNA
Blood, lymphatic tissues and anogenital swabs.

Enrollment: 21
Study Start Date: September 2008
Study Completion Date: January 2013
Primary Completion Date: January 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01460433


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
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:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01460433     History of Changes
Other Study ID Numbers: 0712M22449
P01AI074340 ( U.S. NIH Grant/Contract )
First Submitted: October 24, 2011
First Posted: October 26, 2011
Last Update Posted: September 5, 2014
Last Verified: September 2014

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

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