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Completed

NCT Number: NCT01679067

Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients

To date, despite the known benefits of antiretroviral therapy (ART), many HIV-infected people are presenting late with very low CD4+ T-cells levels below 350/ul. These patients are more likely to be diagnosed with opportunistic infections, their risk of death is higher and their rate of immunological improvement is slower (Mussini C et al., 2008). These patients often present a real challenge due to their advanced clinical status (Borghi V et al., 2008). Unfortunately, little is known about the clinical presentation of these patients, their responses to antiretroviral treatment and especially about the changes in the adaptive and innate immunity of the GALT.

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Key information

Conditions

HIV Infection 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 Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cologne

Cologne, 50937, Germany

About this study

The investigator proposes to evaluate the virological, immunological and clinical outcomes of ART in HIV-1 infected 'late presenters'. The investigator further wants to investigate the longitudinal dynamics of the innate and adaptive immunity restoration in the GALT and peripheral blood of HIV infected patients under ART. In particular the investigators want to longitudinally assess DCs, NK-cells, CD4+ T-cells und CD45RO+-T-cells as well as the levels of IFNγ, IFNα, TNFα, and IL-12 in the GALT and peripheral blood by flow cytometry and by real-time PCR and correlate these data with laboratory and clinical parameters.

The investigators expect that this longitudinal study and experiments outlined in the protocol will provide valuable information about several important issues of the clinical outcome of patients under ART as well as understanding immunopathology during HIV-infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented HIV infection
  • Patients naive to antiretroviral treatment
  • Age older than 18 years
  • Indication for initiation of ART
  • Informed consent

Exclusion criteria

  • Patients on antiretroviral treatment
  • No informed consent
  • Estimated life expectancy <1 year
  • Age <18 years

Treatment and study plan

colonoscopy with endoscopic biopsies

Procedure

Primary outcomes

  1. restoration of CD4 + T-cells in the GALT with ART

    Time frame: 6 months

Secondary outcomes

  1. Function of Dendritic Cells (DC) in the GALT with ART

    Time frame: 6 months

    Functional characterization of DCs (IFNγ, IFNα) of DCs in the GALT

  2. Functional characterization of NK-cells in the GALT with ART

    Time frame: 6 months

    Functional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART

Sponsors and collaborators

Lead sponsor

Clara Lehmann

Other

Collaborators

  • German Federal Ministry of Education and Research

Registry information

Official study title

Phase IV Longitudinal Study of Gut Associated Lymphatic Tissue (GALT) in HIV (Human Immunodeficiency Virus)- Infected Patients Before and During Antiretroviral Therapy (ART)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2012
Registry last updated
Jan 13, 2016

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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