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

NCT02411071 | Unknown

• 2 other identifiers: 14-6155-BOTMC114IFD4043
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-infection

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• Patterns associated with LLV or PV

  In the last 10 years

• Detection of gag mutations

  In the last 10 years

• HIV tropism during LLV or PV

  In the last 10 years

• Cellular inflammation markers

  In the last 10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- no antiretroviral therapy / treatment

Sponsors & Collaborators

• University Hospital, Essen: lead
• Janssen Medical Affairs: collaborator

Study Sites (1)

HIV outpatient center, Dept. for Dermatology and Venerolgy, University Duisburg-Essen, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Biospecimen

Retention: NONE RETAINED

Cells and DNA/RNA extracted from whole blood samples

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD M.D.

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: April 8, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

DE (1)