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

December 2, 2015 updated by: Jens Verheyen, University Hospital, Essen
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • NRW
      • Essen, NRW, Germany, 45147
        • HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- no antiretroviral therapy / treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of low-level viremia (LLV) during ART
Time Frame: In the last 10 years
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
Time Frame: In the last 10 years
Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment
In the last 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns associated with LLV or PV
Time Frame: 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.
In the last 10 years
Detection of gag mutations
Time Frame: In the last 10 years
In the last 10 years
HIV tropism during LLV or PV
Time Frame: In the last 10 years
Determination of the HIV tropism during LLV or PV in a subset of patients
In the last 10 years
Cellular inflammation markers
Time Frame: In the last 10 years
Number of Tregs in the peripheral blood. Number of central memory and effector cells.
In the last 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

December 3, 2015

Last Update Submitted That Met QC Criteria

December 2, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 14-6155-BO
  • TMC114IFD4043 (Other Grant/Funding Number: Janssen-Cilag Medical Affairs EMEA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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