Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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HIV-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- no antiretroviral therapy / treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jens Verheyen

PD M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Verheyen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Virology, University Duisburg-Essen, University Hospital Essen, Essen, Germany

Stefan Esser, M.D.

Role: PRINCIPAL_INVESTIGATOR

HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen, Essen, Germany

Locations

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HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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TMC114IFD4043

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-6155-BO

Identifier Type: -

Identifier Source: org_study_id