Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC114IFD4043 | Other Grant/Funding Number | Janssen-Cilag Medical Affairs EMEA |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Medical Affairs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy in Essen (Germany) from 2004 on. Stored samples from selected patients (n=50) obtained for routine diagnostics will be used to analyze the gag gene, the V3-region of the env gene and immune cells.
The underlying study is a retrospective analysis of HIV-1 positive patients treated with antiretroviral therapy from Essen since 2004. Stored samples obtained for routine diagnostics will be used to analyze the gag gene, the V3-region and immune cells from selected patients. By comparing different groups of patients this study aims to identify clinical implications of low-level viremia (LLV) and persistent viremia (PV) at times of highly active antiretroviral treatment regimens (cART). The objectives of this study is to (1) determine how often LLV and PV occured during cART in Essen in the last 10 years and whether specific patterns can be correlated, (2) whether the evolution of PI drug resistance can be detected earlier in the gag than in the protease gene, (3) what kind of cellular tropism do HIV-1 isolates (RNA and proviral DNA) have at times of LLV, and (4) what kind of immune cells circulate in the blood during LLV and PV and what kind of functional properties do they have. The groups include patients starting cART as well as patients with cART. Furthermore, clinical data of patients are routinely documented and will be combined with results specifically obtained in this study in an anonymized data set. Since this is a retrospective study, there are no specific endpoints.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients starting cART | Patients starting cART. Grouping according to the time needed to reach viral loads below 1000, 500, 400, 200, 50 copies/ml, respectively. | ||
| Patients with cART | Patients with cART. Grouping in patients without and with low-level-viremia (LLV) defined as two consecutive viral loads between 40 copies/ml and 200 copies/ml, 400 copies/ml, 500 copies/ml and 1000 copies/ml, respectively. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Frequencies of low-level viremia (LLV) during ART | Viral loads between 40 and 1000 copies/ml at two consecutive time points preceded by undetectable viral loads | In the last 10 years |
| Frequencies of persistant viremia (PV) after start of ART | Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment | In the last 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns associated with LLV or PV | CD4+ cell count, the CD4:CD8 ratio and the number of activated T cells (HLA-DR+), NK-cells (CD3-, CD16+, CD56+) and cytotoxic T-cells (CD3+, CD16+, CCD56+), HBV/HCV Co-Infection status. | In the last 10 years |
| Detection of gag mutations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- no antiretroviral therapy / treatment
Not provided
Not provided
Not provided
A database comprising clinical parameters (viral Ioad, antiretroviral treatment, immunological parameters, HBV/HCV-coinfections and HIV-1 genotypes) of patients treated in Essen in the last 10 years will be set up. These data will be used to compare different groups of patients and will be screened for parameters associated with LLV (defined as two consecutive viral loads between 40 and 1000 copies/ml) or PV (viral loads between above 50 copies/ml 26 weeks after start of ART). Different clinical settings will be distinguished: First patients after the start of first line treatment regimens in the initial phase and second patients after at least 18 months of cART.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Verheyen, M.D. | Institute of Virology, University Duisburg-Essen, University Hospital Essen, Essen, Germany | Principal Investigator |
| Stefan Esser, M.D. | HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen, Essen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Cells and DNA/RNA extracted from whole blood samples
| In the last 10 years |
| HIV tropism during LLV or PV | Determination of the HIV tropism during LLV or PV in a subset of patients | In the last 10 years |
| Cellular inflammation markers | Number of Tregs in the peripheral blood. Number of central memory and effector cells. | In the last 10 years |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |