B24
Conditions
Interventions
Group 1: group with blips (positive HI viral load 50cop/ml - 400cop/ml and the frequency of therapeutic adjustment
Sponsors
mib-Dienstleistungs-GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients are recruited from the normal patient pool of the participating practises. The following criteria have to be fulfilled: • the signed informed consent [ • a documented HIV-1 infection • age =18 • on ART treatment (it is also sufficient: - to plan an ART in the next three month after inclusion into the study; - short interruptions of ART due to medical indications or “drug holidays” of max. 90 days, this is not valued as a stopping of ART.
Exclusion criteria
Exclusion criteria: • participation in clinical trials • patient not competent to sign informed consent • missing of sufficient documentation of parameters in the patients records
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How often is a therapeutic change in patients on antiretroviral therapy (ART) liable to positive HIV-1 viremia. Therapeutic change is defined by any readjustment of ART. | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of groups of ART-receiving patients with measurable viral loads having: • A blip (one viral load up to 400 copies per mL) and possible therapy changes • A low level viremia (at least two consecutive viral loads above 50 but below 400 copies per mL and possible therapy changes • A measurable viral load above 400 copies per mL and possible therapy changes For each group the influence of following parameters is examined: • Existing HIV-1 resistance profiles • Newly resistance developments (virologic failure on ART) • Actual ART substance-classes • ART substance-classes after therapeutic adjustment • Markers of immuneactivation (activated lymphocytes CD8+/CD38+, +/- HLA-DR, CRP, IL-6) • Co-infections (STI HCV) • Vaccinations • co morbidities (opportunistic infections, malignant tumours) • additional therapeutic monitoring (repeated viral load measurements, therapeutic drug monitoring) • age, sex, body weight In the end analyses should make it possible to define a threshold of viral load with rising risk of therapy failure above. | — |
Countries
Germany
Contacts
Public ContactMartin Obermeier
mib-Dienstleistungs-GmbH
Outcome results
None listed