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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679067
• Other study ID #: GALT-HIV
• Status: Completed
• Phase: N/A
• First received: August 31, 2012
• Last updated: January 12, 2016
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research ':'
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Procedure:
• colonoscopy with endoscopic biopsies

Locations

Country	Name	City	State
Germany	University of Cologne	Cologne

Sponsors (2)

Lead Sponsor	Collaborator
Clara Lehmann	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	restoration of CD4 + T-cells in the GALT with ART		6 months	No
Secondary	Function of Dendritic Cells (DC) in the GALT with ART	Functional characterization of DCs (IFN?, IFNa) of DCs in the GALT	6 months	No
Secondary	Functional characterization of NK-cells in the GALT with ART	Functional characterization on NK- cells (TNFa, and IL-12) in the GALT with ART	6 months	No