- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02411071
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.
Sponsor
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
Additional Relevant MeSH Terms
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.
Clinical Trials on HIV-infection
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Sociedad Andaluza de Enfermedades InfecciosasConsejeria de Salud. Junta de Andalucia. SpainCompletedHIV Infection | HIV-1 InfectionSpain
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
Rockefeller UniversityCompletedHIV Infection | Healthy Volunteers | HIV-1 InfectionUnited States
-
Erasmus Medical CenterRecruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
Erasmus Medical CenterActive, not recruitingHIV Infections | HIV-1-infection | HIV-2 InfectionNetherlands
-
AIDS Healthcare FoundationUniversity of California, Los AngelesCompleted
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...CompletedHIV-1 Infection | HIV Antibodies | Neutralizing Antibody | Viral Load | Monoclonal AntibodyUnited States