Antiretroviral therapy and peripheral T cell apoptosis

Completed

• Conditions: HIV; Human immunodeficiency virus; 10047438

• Registration Number: NL-OMON37267
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>T cell apoptosis is measured by Annexin V and propidium idodide stainings. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Furthermore, caspase-activity will be evaluated as well as T cell phenotypes.</p><br>