Refine
Has Fulltext
- yes (10)
Is part of the Bibliography
- yes (10)
Document Type
- Journal article (10)
Language
- English (10)
Keywords
- HIV (7)
- antiretroviral therapy (2)
- ACH-2 (1)
- AIDS (1)
- Braak (1)
- CSF (1)
- DAT (1)
- Dendritische Zelle (1)
- GFAP (1)
- HAND (1)
- HIV diagnosis and management (1)
- HIV infections (1)
- HIV neurocognitive impairment (1)
- Immunstimulation (1)
- Parkinson (1)
- Placebo (1)
- Prednisolon (1)
- R0 (1)
- SARS-CoV-2 (1)
- South Africa (1)
- Tansania (1)
- Tanzania (1)
- antimicrobial resistance (1)
- antiretrovirals (1)
- autoantibodies (1)
- dopamine (1)
- drug adherence (1)
- heroine (1)
- highly-active antiretroviral therapy (1)
- human immunodeficiency virus (1)
- human peripheral blood (1)
- immune activation (1)
- injecting drug users (1)
- lithium (1)
- morphine (1)
- mortality (1)
- mutation databases (1)
- naloxone (1)
- opioids (1)
- polymorphism (1)
- randomized controlled clinical trial (1)
- reactivation (1)
- sequence databases (1)
- viral load (1)
- viral replication (1)
Institute
- Institut für Virologie und Immunbiologie (10)
- Institut für Mathematik (2)
- Klinik und Poliklinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie (1)
- Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie (1)
- Medizinische Klinik und Poliklinik I (1)
- Medizinische Klinik und Poliklinik II (1)
- Missionsärztliche Klinik (1)
- Neurologische Klinik und Poliklinik (1)
- Pathologisches Institut (1)
- Theodor-Boveri-Institut für Biowissenschaften (1)
Background
HIV-disease progression correlates with immune activation. Here we investigated whether corticosteroid treatment can attenuate HIV disease progression in antiretroviral-untreated patients.
Methods
Double-blind, placebo-controlled randomized clinical trial including 326 HIV-patients in a resource-limited setting in Tanzania (clinicaltrials.gov NCT01299948). Inclusion criteria were a CD4 count above 300 cells/μl, the absence of AIDS-defining symptoms and an ART-naïve therapy status. Study participants received 5 mg prednisolone per day or placebo for 2 years. Primary endpoint was time to progression to an AIDS-defining condition or to a CD4-count below 200 cells/μl.
Results
No significant change in progression towards the primary endpoint was observed in the intent-to-treat (ITT) analysis (19 cases with prednisolone versus 28 cases with placebo, p = 0.1407). In a per-protocol (PP)-analysis, 13 versus 24 study participants progressed to the primary study endpoint (p = 0.0741). Secondary endpoints: Prednisolone-treatment decreased immune activation (sCD14, suPAR, CD38/HLA-DR/CD8+) and increased CD4-counts (+77.42 ± 5.70 cells/μl compared to -37.42 ± 10.77 cells/μl under placebo, p < 0.0001). Treatment with prednisolone was associated with a 3.2-fold increase in HIV viral load (p < 0.0001). In a post-hoc analysis stratifying for sex, females treated with prednisolone progressed significantly slower to the primary study endpoint than females treated with placebo (ITT-analysis: 11 versus 21 cases, p = 0.0567; PP-analysis: 5 versus 18 cases, p = 0.0051): No changes in disease progression were observed in men.
Conclusions
This study could not detect any significant effects of prednisolone on disease progression in antiretroviral-untreated HIV infection within the intent-to-treat population. However, significant effects were observed on CD4 counts, immune activation and HIV viral load. This study contributes to a better understanding of the role of immune activation in the pathogenesis of HIV infection.