HIV-infectionNCT02411071
Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
An observational study of HIV-infection, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-infection
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Chronic HIV-1 infection
- Age > 18 years
- Patients treated in Essen in the last 10 years
Who cannot join
- no antiretroviral therapy / treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen
Essen, North Rhine-Westphalia, 45147
About this study
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.
Read the 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.
- Conditions
- HIV-infection
- Keywords
- HIV-1, antiretroviral treatment, low viral load, low-level viremia
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of low-level viremia (LLV) during ART
Viral loads between 40 and 1000 copies/ml at two consecutive time points preceded by undetectable viral loads
Measured: In the last 10 years
Frequencies of persistant viremia (PV) after start of ART
Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment
Measured: In the last 10 years
Secondary outcomes (4)
Patterns associated with LLV or PV
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.
Measured: In the last 10 years
Detection of gag mutations
Measured: In the last 10 years
HIV tropism during LLV or PV
Determination of the HIV tropism during LLV or PV in a subset of patients
Measured: In the last 10 years
Cellular inflammation markers
Number of Tregs in the peripheral blood. Number of central memory and effector cells.
Measured: In the last 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Medical Affairs
- Responsible party
- Principal investigator, Jens Verheyen, University Hospital, Essen
- Investigators
- Jens Verheyen, M.D., Principal investigator, Institute of Virology, University Duisburg-Essen, University Hospital Essen, Essen, GermanyStefan Esser, M.D., Principal investigator, HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411071
- Sponsor's protocol ID
- 14-6155-BO
- Other IDs
- TMC114IFD4043
- Status last verified
- Dec 2015
- First submitted
- 6 Mar 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
- ClinicalTrials.gov ID
- NCT02411071
- Acronym / sponsor ID
- 14-6155-BO
- Conditions
- HIV-infection
- Keywords
- HIV-1, antiretroviral treatment, low viral load, low-level viremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Janssen Medical Affairs
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Chronic HIV-1 infection
- Age > 18 years
- Patients treated in Essen in the last 10 years
Key exclusion criteria (1 listed)
- no antiretroviral therapy / treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
Patterns associated with LLV or PV
Time frame: In the last 10 years
Detection of gag mutations
Time frame: In the last 10 years
HIV tropism during LLV or PV
Time frame: In the last 10 years
Cellular inflammation markers
Time frame: In the last 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Verheyen, M.D. principal investigator
Institute of Virology, University Duisburg-Essen, University Hospital Essen, Essen, Germany
Stefan Esser, M.D. principal investigator
HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen, Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-infection, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of low-level viremia (LLV) during ART (time frame: In the last 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.