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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



Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome

For Condition: Meningitis, Cryptococcal,HIV Infections
Status: Completed
Sponsor(s): Liposome ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Dose Comparison, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 

Location and Contact Information:

Audie L Murphy Veterans Administration Hosp
San Antonio,  Texas,  78284
United States
 

Rush Presbyterian - Saint Luke's Med Ctr
Chicago,  Illinois,  60612
United States
 

East Orange Veterans Administration Med Ctr
East Orange,  New Jersey,  07018
United States
 

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10025
United States
 

Univ TX Galveston Med Branch
Galveston,  Texas,  77550
United States
 

Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York City,  New York,  10029
United States
 

Dr Thomas Patterson
New Haven,  Connecticut,  06510
United States
 

Univ of Utah School of Medicine
Salt Lake City,  Utah,  84132
United States
 

Buckley Braffman Stern Med Associates
Philadelphia,  Pennsylvania,  19107
United States
 

Natl Naval Med Ctr
Bethesda,  Maryland,  20889
United States
 

Dr Dorothy Friedberg
New York City,  New York,  10016
United States
 

Harbor - UCLA Med Ctr
Torrance,  California,  90502
United States
 

New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Walter Reed Army Med Ctr
Washington D.C.,  District of Columbia,  203075001
United States
 

Saint Michael's Med Ctr
Newark,  New Jersey,  07102
United States
 

Cornell Univ Med College
New York City,  New York,  10021
United States
 

Beth Israel Med Ctr / Peter Krueger Clinic
New York City,  New York,  10003
United States
 

Univ Hosp
Boston,  Massachusetts,  02118
United States
 


Additional Information:
Study ID Numbers:
  051A; 
Study Start Date: 
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002019

Other Meningitis, Cryptococcal Studies:
1. An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis

2. Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis

3. A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis

4. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success with Amphotericin B

5. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome

Related Studies:

Other Meningitis, Cryptococcal Clinical Trials
Other Maryland Clinical Trials
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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

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