Clinical trial NCT02411071: Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
Official title: Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV-infection
Keywords: HIV-1
antiretroviral treatment
low viral load
low-level viremia
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: Janssen Medical Affairs
First posted: 2015-04-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Chronic HIV-1 infection
* Age \> 18 years
* Patients treated in Essen in the last 10 years

Exclusion Criteria:

- no antiretroviral therapy / treatment

Primary outcomes:
measure: Frequencies of low-level viremia (LLV) during ART
timeFrame: In the last 10 years
measure: Frequencies of persistant viremia (PV) after start of ART
timeFrame: In the last 10 years
Secondary outcomes:
measure: Patterns associated with LLV or PV
timeFrame: In the last 10 years
measure: Detection of gag mutations
timeFrame: In the last 10 years
measure: HIV tropism during LLV or PV
timeFrame: In the last 10 years
measure: Cellular inflammation markers
timeFrame: In the last 10 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen
state: NRW
Study officials:
affiliation: Institute of Virology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
name: Jens Verheyen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen, Essen, Germany
name: Stefan Esser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: