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TerminatedNCT00847678Updated Feb 19, 2009

Efficacy and Safety of Mycograb as Adjunctive Therapy for Cryptococcal Meningitis in Patients With AIDS

A Phase 2 interventional study of Efungumab (Mycograb) and placebo in Cryptococcal Meningitis, sponsored by Novartis Pharmaceuticals. Terminated at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-19.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter, randomized, efficacy and safety trial to evaluate Mycograb®. Subjects will be randomized to one of the 3 arms: 1/ Amphotericin B (0.7 mg/kg/d) plus 5-flucytosine (100 mg /kg/d); 2/ Amphotericin B plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days); 3/ Amphotericin B plus 5-flucytosine plus Mycograb® (dosed 1 mg/kg via a central line or peripheral venous line twice daily for 7 consecutive days). After 2 weeks, all patients will be switched to fluconazole at 400 mg/d for 8 weeks and 200 mg/d thereafter. The total duration of the study will be approximately 24 months

02

Conditions studied

  • Cryptococcal Meningitis

Keywords

  • Cryptococcal Meningitis
03

In context

Meningitis, Cryptococcal

54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.

This study's enrollment of 38 is below the median of 143 across 35 interventional studies indexed under Meningitis, Cryptococcal.

Browse Meningitis, Cryptococcal studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.

Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.

Browse Novartis Pharmaceuticals studies →All Novartis studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or non-pregnant female who is > 18 years old.
  • -positive or unknown, with acute, either first or recurrent episode of cryptococcal meningitis.
  • Currently on no treatment, or receiving treatment (\< 3 days) with either amphotericin B plus 5-flucytosine, or amphotericin B alone.
  • Positive CSF culture for Cryptococcus neoforman.
  • Physical signs and symptoms of meningitis, evidenced by one or more of the following: fever, headache, meningeal signs and neurologic findings.

Exclusion criteria

Exclusion criteria:

  • Excluded for coma, or significant other medical conditions.
  • Subject has other opportunistic fungal infections that requires other systemic antifungal therapies.

Other protocol-defined inclusion/exclusion criteria may apply

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    1

    Mycograb + Amphotericin B + 5 flucytosine

    Biological: Efungumab (Mycograb) · Biological: Amphotericin B · Biological: 5 flucytosine

  • Placebo comparator
    2

    Placebo + Amphotericin B + 5 flucytosine

    Biological: placebo · Biological: Amphotericin B · Biological: 5 flucytosine

  • Experimental
    3

    Mycograb + Amphotericin B

    Biological: Efungumab (Mycograb) · Biological: Amphotericin B

Interventions

06

What researchers measure

Primary outcomes

  1. proportion of patients (receiving Mycograb + Amphotericin B + 5-flucytosine) cured (combined clinical and microbiological response) versus placebo (Amphotericin B + 5-flucytosine) and versus Mycograb + Amphotericin B alone.

    Time frame: day 14

Secondary outcomes

  1. Safety of Mycograb versus placebo. Safety assessment will include: physical examination, vital signs, laboratory parameters, adverse events, serious adverse events.

    Time frame: week 10

  2. Assess the cerebrospinal fluid (CSF) penetration of Mycograb

    Time frame: Days 3, 7 and 14

  3. Determine whether Mycograb + Amphotericin B is as effective as Amphotericin B plus 5-cytosine while avoiding the potential problem of 5-cytosine toxicity.

    Time frame: Day 14

07

Study locations

1 site
  • Novartis Investigative Site
    South Africa, South Africa
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006 and a primary completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2009
First posted
Feb 19, 2009
Start
Aug 2006
Primary completionActual
Nov 2007
Last update
Feb 19, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00847678
Lead sponsor
Novartis Pharmaceuticals
First posted
Feb 19, 2009
Start date
Aug 2006
Primary completion
Nov 2007
Last update
Feb 19, 2009

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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