NCT04072640

Three Induction Treatments on Cryptococcal Meningitis

The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cryptococcal Meningitis
• HIV/AIDS

Interventions

Type	Name	Description
DRUG	Voriconazole 200mg	Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
DRUG	amphotericin B deoxycholate (0.4-0.5mg/kg/d)	Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
DRUG	Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)	Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-07-31
• Completion: 2022-12-01
• First posted: 2019-08-28
• Last updated: 2021-02-02

Locations

1 site across 1 country: China