Three Induction Treatments on Cryptococcal Meningitis (TITOC)

Zhejiang University

Status and phase: Unknown; Early Phase 1

Conditions: HIV/AIDS; Cryptococcal Meningitis

Treatments: Drug: Voriconazole 200mg; Drug: amphotericin B deoxycholate (0.4-0.5mg/kg/d); Drug: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)

Study type: Interventional

Funder types: Other

Identifiers

NCT04072640

2018-014-1

Details and patient eligibility

About

Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.

Full description

HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of HIV infection;
2. newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);
3. Anti-viral treatment naïve patients
4. anti-fungal treatment naïve patients

Exclusion criteria

1. hepatitis virus co-infection;
2. liver cirrhosis;
3. congestive heart failure;
4. chronic renal disorders;
5. chronic obstructive pulmonary disease (COPD);
6. Tuberculosis co-infection;
7. malignances
8. severe mental and neurological diseases
9. Women during pregnancy and lactation
10. intraveneous drug user (IDU)
11. patients with follow abnormal test results:hemoglobin < 6 g/dl, white blood cell count < 2000 / μl, neutrophil count < 1000 / μl, platelet count < 75000 / μl, blood amylase > 3 times normal level Upper limit, serum creatinine > 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase > 3 times normal upper limit, total bilirubin > 2 times normal upper limit
12. patients who are unwilling to anticipate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

voriconazole treatment

Experimental group

Description:

induction treatment with Voriconazole 200mg bid (IV) + 5FC (100mg/kg/d) for 14 days, consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

Treatment:

Drug: Voriconazole 200mg

amphotericin treatment (0.7-1.0mg/kg/d)

Active Comparator group

Description:

Induction treatment with amphotericin B 0.7-1.0mg/kg/d + 5FC (100mg/kg/d) for 14 days,consolidation treatment wiht fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

Treatment:

Drug: Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)

amphotericin B treatment (0.4-0.5mg/kg/d)

Experimental group

Description:

Induction treatment with amphotericin B 0.4-0.5mg/kg/d + 5FC (100mg/kg/d) for 28 days, consolidation treatment with fluconazole 400mg/d for two months, then maintenance treatment with fluconazole 200mg/d

Treatment:

Drug: amphotericin B deoxycholate (0.4-0.5mg/kg/d)