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)
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University of Cologne | Cologne |
Lead Sponsor | Collaborator |
---|---|
Clara Lehmann | German Federal Ministry of Education and Research |
Germany,
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 |
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