Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
- Conditions
- HIV-infection
- Registration Number
- NCT02411071
- Lead Sponsor
- University Hospital, Essen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Chronic HIV-1 infection
- Age > 18 years
- Patients treated in Essen in the last 10 years
- no antiretroviral therapy / treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequencies of low-level viremia (LLV) during ART In the last 10 years Viral loads between 40 and 1000 copies/ml at two consecutive time points preceded by undetectable viral loads
Frequencies of persistant viremia (PV) after start of ART In the last 10 years Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment
- Secondary Outcome Measures
Name Time Method Patterns associated with LLV or PV In the last 10 years 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.
Detection of gag mutations In the last 10 years HIV tropism during LLV or PV In the last 10 years Determination of the HIV tropism during LLV or PV in a subset of patients
Cellular inflammation markers In the last 10 years Number of Tregs in the peripheral blood. Number of central memory and effector cells.
Trial Locations
- Locations (1)
HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen
🇩🇪Essen, NRW, Germany
HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen🇩🇪Essen, NRW, Germany