Clinical trial NCT00002019: Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Official title: Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningitis, Cryptococcal
HIV Infections
Keywords: Meningitis
Liposomes
Cryptococcosis
Acquired Immunodeficiency Syndrome
Amphotericin B
Chemistry, Pharmaceutical
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: New Haven
country: United States
facility: Dr Thomas Patterson
state: Connecticut
city: Washington
country: United States
facility: Walter Reed Army Med Ctr
state: District of Columbia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Bethesda
country: United States
facility: Natl Naval Med Ctr
state: Maryland
city: Boston
country: United States
facility: Univ Hosp
state: Massachusetts
city: East Orange
country: United States
facility: East Orange Veterans Administration Med Ctr
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Med Ctr
state: New Jersey
city: New York
country: United States
facility: Beth Israel Med Ctr / Peter Krueger Clinic
state: New York
city: New York
country: United States
facility: Dr Dorothy Friedberg
state: New York
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Cornell Univ Med College
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr / Jack Martin Fund Clinic
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah School of Medicine
state: Utah
Study officials:
References:
citation: al-Haddadin D, Fan-Havard P, Boghossian J, Marton R, Vincent-Graber D, Dungo L, Eng RH, Johnson ES. Amphotericin B-lipid complex (ABLC) in treatment of cryptococcal meningitis in AIDS. Int Conf AIDS. 1992 Jul 19-24;8(2):B109 (abstract no PoB 3132)