Why carry out the study?
| |
Recurrence of symptoms is prevalent and sometimes fatal in HIV-infected individuals with cryptococcal meningitis. | |
Treatment option is limited for symptom recurrence without fungal relapse. | |
What was learned from the study?
| |
Thalidomide treatment led to clinical and radiological resolution, and showed safety in this pilot study. | |
Randomized clinical trials are needed to further declare the efficacy and safety of thalidomide therapy. |
Introduction
Methods
Results
Demographic data | N = 16 |
---|---|
Gender, no. of males (%) | 12 (75) |
Median age in years (IQR) | 43 (32,56) |
Race (%) | Chinese (100) |
Species (%) | C. neoforman (100) |
Categorization of symptom recurrence | |
Paradoxical IRIS | 5 (31) |
Persistent elevated ICP only | 6 (38) |
Persistent symptom only | 5 (31) |
Median time from start of ART treatment to symptom recurrence in days (IQR) | 171 (19, 361) |
Median time from recurrence to thalidomide usage | 13 (6, 29) |
Corticosteroid usage before thalidomide, no. (%) | 11 (69) |
Patients with ventriculoperitoneal shunt, no. (%) | 2 (13) |
Patients with Underlying comorbidities, no. (%) | 4 (25) |
Diabetes mellitus | 1 (6) |
Horseshoe kidney | 1 (6) |
Cytomegalovirus retinitis | 1 (6) |
Hepatitis B | 1 (6) |
Myocardial bridge | 1 (6) |
Lung cancer | 1 (6) |
Nadir CD4 count (cells/μL, IQR) | 28 (11, 53) |
CD4 count before thalidomide usage (cells/μL, IQR) | 72 (48, 86) |
ARVs | |
Efavirenz based | 6 (38%) |
Lopinavir/ritonavir based | 1 (17%) |
Integrase inhibitors based | 9 (56%) |
Signs and symptoms | Primary, no. (%) | At recurrence, no. (%) | P |
---|---|---|---|
Headache | 13 | 11 | NS |
Altered mental status | 1 | 5 | NS |
Faint | 4 | 2 | NS |
Vision change | 1 | 6 | 0.03 |
Hearing loss | 0 | 1 | NS |
Nausea/vomiting | 8 | 1 | 0.006 |
Fever | 4 | 1 | NS |
Imbalance | 0 | 4 | NS |
Speech deficits | 0 | 1 | NS |
No. (%) | Time since thalidomide usage (days) | |
---|---|---|
Time of visit | 16 (100) | 295 (166, 419) |
Survival | 16 (100) | |
Clinical improvement | 16 (100) | 7 (4, 20) |
Complete resolution of symptoms* | 9 (56)* | 187 (131, 253) |
Radiological improvement (n = 13) | 11 (85) | 36 (10, 121) |
Complete radiological resolution (n = 13) | 1 (8) | 178 |
Reduction of thalidomide dosage | 15 (94) | 45 (28, 87) |
Thalidomide withdraw | 6 (38) | 70 (46, 195) |
CSF parameters | Before median (range) n = 16 | After median (range) n = 13 | P |
---|---|---|---|
Intracranial pressure (mmH2O) | 260 (120, 330) | 228 (80, 330) | NS |
WBC (/mm3) | 7 (2, 66) | 7 (2, 22) | NS |
Total protein (mg/L) | 857 (325, 2045) | 747 (179, 2451) | NS |
CSF glucose (mmol/L) | 3.0 (1.82, 4.46) | 3.0 (1.64, 6.8) | NS |
AE | No. (%) | AE attributable to thalidomide, no. (%) |
---|---|---|
Allergy | 1 (6) | 1 (6) |
Elevated ALT* | 2 (13) | 2 (13) |
Chest pain | 1 (6) | 0 |
Hypertension | 2 (13) | 0 |
Hypokalemia | 1 (6) | 0 |
Anemia | 1 (6) | 0 |
Cerebral infarction | 1 (6) | 0 |
Overall SAE** | 1 (6) | 0 |
Thalidomide withdraw due to AE | 0 | 0 |
AE | 50 mg n = 2 | 75 mg n = 8 | 100 mg n = 6 | P |
---|---|---|---|---|
Allergy | 0 | 1 | 0 | NS |
Elevated ALT | 1 | 1 | 0 | NS |
Any AE | 2 | 3 | 3 | NS |