NCT00002019CompletedNot Applicable
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
Liposome31 sites in 1 countryStarted: August 31, 2001Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 31
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •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:
- •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.
Investigators
Study Sites (31)
Loading locations...
Similar Trials
Completed
Not Applicable
A observational study for effects of Amphotericin B in two different doses in Post Kala-Azar Dermal Leishmaniasis (PKDL)CTRI/2016/05/006958Intramural Projects of RMRIMS ICMR50
Unknown
Not Applicable
Liposomal Amphotericin B for the Treatment of Cryptococcal MeningitisCryptococcal MeningitisNCT02136030TTY Biopharm84
Completed
Not Applicable
Clinical Effectiveness and Safety of Amphotericin B With Flucytosine-Fluconazole Therapy for Cryptococcal MeningitisCryptococcal MeningitisNCT04532463University of Pharmacy, Yangon30
Completed
Phase 1
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed ConditionVisceral LeishmaniasisNCT03636659Aurobindo Pharma Ltd140
Completed
Phase 4
Topical Amphotericin B in 30% Dimethylsulphoxide in Treating of Non-dermatophytes OnychomycosisFungus, NailFungal InfectionOnychomycosisNCT03814343Mahidol University19