Meningitis, CryptococcalNCT00002019
Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
A study testing Amphotericin B, Lipid-based and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Liposome at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Amphotericin B, Lipid-based and Amphotericin B
- How many people
- Not given
- Where
- 19 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 27Show fewer
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Natl Naval Med Ctr
Bethesda, Maryland, 20889
Univ Hosp
Boston, Massachusetts, 02118
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Dr Thomas Patterson
New Haven, Connecticut, 06510
Beth Israel Med Ctr / Peter Krueger Clinic
New York, New York, 10003
Dr Dorothy Friedberg
New York, New York, 10016
New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med College
New York, New York, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
Mount Sinai Med Ctr / Jack Martin Fund Clinic
New York, New York, 10029
Mount Sinai Med Ctr
New York, New York, 10029
Saint Michael's Med Ctr
Newark, New Jersey, 07102
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284
Harbor - UCLA Med Ctr
Torrance, California, 90502
Walter Reed Army Med Ctr
Washington D.C., District of Columbia, 203075001
About this study
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.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Amphotericin B, Lipid-based, Amphotericin B
- Keywords
- Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, Meningitis, Cryptococcosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin B, Lipid-basedDrug
Amphotericin BDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Liposome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002019
- Sponsor's protocol ID
- 051A
- Status last verified
- Nov 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT00002019
- Acronym / sponsor ID
- 051A
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- Meningitis, Liposomes, Cryptococcosis, Acquired Immunodeficiency Syndrome, Amphotericin B, Chemistry, Pharmaceutical
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- LiposomeIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Intravenous pentamidine for treatment of Pneumocystis carinii pneumonia (PCP) but not for prophylaxis.
- Meet the CDC criteria for diagnosis of AIDS.
- Confirmed episode of acute cryptococcal meningitis.
- Informed consent of the patient or guardian prior to entry.
Key exclusion criteria (27 listed)
- 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.
- Corticosteroids.
- Salicylates or other drugs known to interfere with prostaglandin synthesis except as specified in protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin B, Lipid-based | Drug | – |
| Amphotericin B | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Backgroundal-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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amphotericin B, Lipid-based and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Liposome at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.