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Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
This study has been completed.
Study NCT00002019   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002019 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome

To evaluate the safety, tolerance and efficacy of three different dosage regimens of Amphotericin B Lipid Complex (ABLC) compared to Fungizone (Amphotericin B) in patients with AIDS and cryptococcal meningitis.

 
 
Interventional
Control:  Dose Comparison
Endpoint Classification:  Safety Study
Primary Purpose:  Treatment
  • Meningitis, Cryptococcal
  • HIV Infections
  • Drug: Amphotericin B, Lipid-based
  • Drug: Amphotericin B
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Intravenous pentamidine for treatment of Pneumocystis carinii pneumonia (PCP) but not for prophylaxis.

Patients must have the following:

  • Meet the CDC criteria for diagnosis of AIDS.
  • Confirmed episode of acute cryptococcal meningitis.
  • Informed consent of the patient or guardian prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
  • History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
  • Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.

Concurrent Medication:

Excluded:

  • Corticosteroids.
  • Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
  • Zidovudine.
  • Investigational agents.
  • Interferon.
  • Interleukin-2 (IL-2).
  • Steroids.
  • Isoprinosine.
  • Intrathecal Amphotericin B.
  • Intravenous Pentamidine PCP prophylaxis (only treatment).

Patients with the following are excluded:

  • Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.
  • History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.
  • Inability to obtain appropriate follow-up visits.
  • Any other concomitant condition which, in the opinion of the investigator, would preclude a patient's participation in the study.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Amphotericin B.
  • Excluded within 2 weeks of study entry:
  • Any other experimental drug.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002019
 
051A
Liposome
 
 
NIH AIDS Clinical Trials Information Service
November 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP