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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02411071

Enrollment

1000

Registered

2015-04-08

Start date

2014-12-31

Completion date

2016-12-31

Last updated

2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infection

Keywords

HIV-1, antiretroviral treatment, low viral load, low-level viremia

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- no antiretroviral therapy / treatment

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results