Problems With Immune Recovery in the Gut Tissue

Human Immunodeficiency Virus Clinical Trial

Official title:

A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460433
• Other study ID #: 0712M22449
• Secondary ID: P01AI074340
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: September 4, 2014
• Start date: September 2008
• Est. completion date: January 2013

Study information

• Verified date: September 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Herpes Simplex Virus - Type 2 shed rate		60 days	No
Secondary	Evidence of HIV replication in blood and lymphoid tissue		60 days	No

External Links

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