Completed

Amphotericin B Lipid Complex Safety and Efficacy in AIDS-Related Cryptococcal Meningitis

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What is being tested

Amphotericin B, Lipid-based

+ Amphotericin B

Drug
Who is being recruted

Blood-Borne Infections+24

+ Neuroinflammatory Diseases

+ Urogenital Diseases

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorLiposome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on evaluating the safety, tolerance, and effectiveness of a medication called Amphotericin B Lipid Complex (ABLC) in treating cryptococcal meningitis, a serious infection of the brain membranes, in patients diagnosed with AIDS. The goal is to compare three different dosage regimens of ABLC with another medication, Fungizone (Amphotericin B), which is currently used for the same condition. The importance of this study lies in its potential to find a safer and more effective treatment option for AIDS patients suffering from cryptococcal meningitis, thereby improving their care and addressing unmet needs in this population. During the study, participants receive either ABLC or Fungizone (Amphotericin B) as per their assigned dosage regimen. The study measures the results by assessing the safety, tolerance, and efficacy of each treatment. Safety and tolerance are evaluated based on observed side effects and patient reactions, while efficacy is determined by how well the treatment controls the infection and improves the patient's condition. Potential risks and benefits associated with each treatment are carefully monitored throughout the study.

Principal SponsorLiposome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBacterial Infections and MycosesCentral Nervous System DiseasesCentral Nervous System InfectionsCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMycosesNervous System DiseasesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMeningitis, FungalCentral Nervous System Fungal InfectionsAcquired Immunodeficiency SyndromeCryptococcosisMeningitisHIV InfectionsMeningitis, Cryptococcal

Criteria

4 inclusion criteria required to participate
Meet the CDC criteria for diagnosis of AIDS.

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

Informed consent of the patient or guardian prior to entry.

Confirmed episode of acute cryptococcal meningitis.

16 exclusion criteria prevent from participating
Isoprinosine.

History of hypersensitivity/anaphylactoid reaction attributed to amphotericin B.

Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.

Clinical evidence of acute or chronic meningitis due to an agent other than Cryptococcus neoformans.

Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 19 locations

Harbor - UCLA Med Ctr

Torrance, United StatesOpen Harbor - UCLA Med Ctr in Google Maps

Dr Thomas Patterson

New Haven, United States

Walter Reed Army Med Ctr

Washington D.C., United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, United States
Completed19 Study Centers