Problems With Immune Recovery in the Gut Tissue

University of Minnesota21 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Human Immunodeficiency Virus

Interventions

Genital and rectal swabbingPROCEDURE

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Herpes Simplex Virus - Type 2 shed rate

Time frame: 60 days

Secondary Outcomes

Evidence of HIV replication in blood and lymphoid tissue

Time frame: 60 days

Data from ClinicalTrials.gov

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