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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01679067
Enrollment
30
Registered
2012-09-05
Start date
2011-06-30
Completion date
2013-06-30
Last updated
2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

HIV, GALT

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.

Interventions

PROCEDUREcolonoscopy with endoscopic biopsies

Sponsors

German Federal Ministry of Education and Research
CollaboratorOTHER_GOV
Clara Lehmann
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
restoration of CD4 + T-cells in the GALT with ART6 months

Secondary

MeasureTime frameDescription
Function of Dendritic Cells (DC) in the GALT with ART6 monthsFunctional characterization of DCs (IFNγ, IFNα) of DCs in the GALT
Functional characterization of NK-cells in the GALT with ART6 monthsFunctional characterization on NK- cells (TNFα, and IL-12) in the GALT with ART

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026