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

HIV-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02411071
• Other study ID #: 14-6155-BO
• Secondary ID: TMC114IFD4043
• Status: Active, not recruiting
• Phase: N/A
• First received: March 6, 2015
• Last updated: December 2, 2015
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• HIV-infection
• Viremia

Locations

Country	Name	City	State
Germany	HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	Janssen Medical Affairs

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In the last 10 years	No
Primary	Frequencies of persistant viremia (PV) after start of ART	Viral loads above 50 copies/ml 26 weeks after start of antiretroviral treatment	In the last 10 years	No
Secondary	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.	In the last 10 years	No
Secondary	Detection of gag mutations		In the last 10 years	No
Secondary	HIV tropism during LLV or PV	Determination of the HIV tropism during LLV or PV in a subset of patients	In the last 10 years	No
Secondary	Cellular inflammation markers	Number of Tregs in the peripheral blood. Number of central memory and effector cells.	In the last 10 years	No