Problems With Immune Recovery in the Gut Tissue

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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 28, 2013
Last verified: August 2013
  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 ] [ 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 ]

Biospecimen Retention:   Samples Without DNA

Blood, lymphatic tissues and anogenital swabs.


Estimated Enrollment: 25
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460433

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Timothy Schacker, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
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 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
HIV 1
Herpes Simplex Type 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 July 28, 2014