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

October 24, 2011
August 28, 2013
September 2008
December 2013   (final data collection date for primary outcome measure)
Herpes Simplex Virus - Type 2 shed rate [ Time Frame: 60 days ] [ Designated as safety issue: No ]
HSV shed rate [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01460433 on ClinicalTrials.gov Archive Site
Evidence of HIV replication in blood and lymphoid tissue [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Problems With Immune Recovery in the Gut Tissue
A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood, lymphatic tissues and anogenital swabs.

Non-Probability Sample

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.

Human Immunodeficiency Virus
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01460433
0712M22449, P01AI074340
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Timothy Schacker, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP