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

NCT ID: NCT01679067

Last Updated: 2016-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-06-30

Brief 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.

Detailed 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.

Conditions

HIV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HIV-GALT

colonoscopy with endoscopic biopsies

Intervention Type: PROCEDURE

Interventions

colonoscopy with endoscopic biopsies

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Clara Lehmann

OTHER

Sponsor Role: lead

Responsible Party

Clara Lehmann

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Cologne

Cologne, , Germany

Countries

Germany

Other Identifiers

GALT-HIV

Identifier Type: -

Identifier Source: org_study_id