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Three Induction Treatments on Cryptococcal Meningitis (TITOC)

Zhejiang University logo

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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