the primary objective is to investigate if HIV-infected patients treated with a NNRTI display higher peripheral T cell apoptosis than those treated with a PI. Secondary objectives are to investigate 1) which apoptosis pathway is involved in…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
T cell apoptosis is measured by Annexin V and propidium idodide stainings.
Secondary outcome
Furthermore, caspase-activity will be evaluated as well as T cell phenotypes.
Background summary
Apoptosis is a fundamental mechanism regulating T cell homeostasis and is
affected by HIV-disease. Preliminary results from the ACATLIFE-study showed
differences in T cell apoptosis between HIV-infected patients with
non-nucleoside reverse transcriptase inhibitor (NNRTI)-based treatment compared
those with protease inhibitor (PI)-based treatment, however these findings were
limited by the set-up and number of included patients.
Study objective
the primary objective is to investigate if HIV-infected patients treated with a
NNRTI display higher peripheral T cell apoptosis than those treated with a PI.
Secondary objectives are to investigate 1) which apoptosis pathway is involved
in antiretroviral treatment (ART)-related T cell apoptosis and 2) which T cell
subsets are predominantly affected in ART-related T cell apoptosis.
Study design
This is an observational cross-sectional study on peripheral blood samples.
Study burden and risks
from each subject, a single peripheral blood sample of 18mL (2 tubes) will be
required. If possible, the visit will be combined with routine visit to the
outpatient clinic at the Department of Internal Medicine and Infectious
Diseases. Participation will not provide individual benefit. Group-related
benefits will include a better understanding of adverse effects of (long term-)
treatment of HIV.
Heidelberglaan 100
3584 CX
NL
Heidelberglaan 100
3584 CX
NL
Listed location countries
Age
Inclusion criteria
- subjects must be willing and able to provide written informed consent
- Age >18 and <65 years
- Body weight >40 and <125kg
- Infected with HIV-1
- Effective HAART >1 year
- subjects must meet the following criteria per patient group:
o *PI-group* (n=15): HAART must consist of a protease inhibitor (e.g. atazanavir, lopinavir, darunavir), boosted with ritonavir, in combination with backbone therapy consisting of tenefovir and emtricitabine but without any other antiretroviral medicine.
o *NNRTI-group* (n=15): HAART must consist of a non-nucleoside reverse transcriptase inhibitor (efavirenz, nevirapine) in combination with backbone therapy consisting of tenofovir and emtricitabine without any other antiretroviral medicine.
Exclusion criteria
- Detectable HIV-RNA within 6 months before inclusion
- CD4-count <350
- Switch of HAART within 6 months before inclusion
- Any known pre-existing condition likely to interfere with T cell apoptosis:
o Systemic infections (other than HIV)
o Systemic auto-immune disease
o Systemic immunomodulatory treatment
o Haematologic disease
o Pregnancy
o Immunodeficiency
- Subjects who are closely related to the investigators of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40589.041.12 |