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OpenTrials
Completed

NCT Number: NCT01460433

Problems With Immune Recovery in the Gut Tissue

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Herpes Simplex Virus - Type 2 shed rate

    Time frame: 60 days

Secondary outcomes

  1. Evidence of HIV replication in blood and lymphoid tissue

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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