Overview

This trial is active, not recruiting.

Condition hiv-infection
Sponsor University Hospital, Essen
Collaborator Janssen Medical Affairs
Start date December 2014
End date December 2016
Trial size 1000 participants
Trial identifier NCT02411071, 14-6155-BO, TMC114IFD4043

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
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. 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.

Primary Outcomes

Measure
Frequencies of low-level viremia (LLV) during ART
time frame: In the last 10 years
Frequencies of persistant viremia (PV) after start of ART
time frame: In the last 10 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Chronic HIV-1 infection - Age > 18 years - Patients treated in Essen in the last 10 years Exclusion Criteria: - no antiretroviral therapy / treatment

Additional Information

Official title Clinical Implications of HIV Low-level Viremia at Times of Highly Active Antiretroviral Treatment Regimens
Principal investigator Jens Verheyen, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Hospital, Essen.