Problems With Immune Recovery in the Gut Tissue

NCT01460433 | Completed

• 2 other identifiers: 0712M22449P01AI074340
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV 1; Herpes Simplex Type 2; Treatment experienced

Outcome Measures

Primary Outcomes (1)

• Herpes Simplex Virus - Type 2 shed rate

  60 days

Secondary Outcomes (1)

• Evidence of HIV replication in blood and lymphoid tissue

  60 days

Interventions

Genital and rectal swabbing PROCEDURE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, lymphatic tissues and anogenital swabs.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Timothy Schacker, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 26, 2011
• Study Start: September 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

US (1)