Meningitis, CryptococcalNCT00002074
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
A study testing Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 39 sites in 2 countries.
Trial summary
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS. 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?
- Fluconazole and Amphotericin B
- How many people
- Not given
- Where
- 39 sitesin 2 countries
- 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:
- Antivirals such as zidovudine.
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
- Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.
- Concurrent Treatment:
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- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must be oriented to person, place, and time, and able to give written informed consent.
- Patients must have had an acute episode of cryptococcal meningitis that was documented by recovery and identification of Cryptococcus neoformans from lumbar cerebrospinal fluid (CSF) culture within 6 months prior to entry.
- Minimum total dose of 15 mg/kg of amphotericin B must have been given (either alone or in combination with flucytosine) during primary therapy.
- Patients need not be receiving amphotericin B at the time of randomization but must begin study maintenance therapy within 6 weeks of completion of primary amphotericin B therapy. Patients may receive maintenance amphotericin B during the period between completion of primary therapy and study entry.
- Prior Medication:
- Allowed:
- Antivirals such as zidovudine (AZT).
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
Who cannot join
- Co-existing Condition:
- Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Concurrent Medication:
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- Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Concurrent Treatment:
- Excluded:
- Lymphocyte replacement.
- Patients with the following are excluded:
- Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Inability to take oral medications reliably.
- Prior Medication:
- Excluded:
- Ketoconazole.
- Fluconazole.
- Itraconazole.
- Miconazole.
- Any systemic imidazole or azole for more than 7 days after initiation of primary therapy for cryptococcosis.
- Intrathecal amphotericin B.
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications.
- Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.
- Prior Treatment:
- Excluded:
- Lymphocyte replacement.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States38 sites
Albany Med College / AIDS Treatment Ctr
Albany, New York, 12203
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
Emory Univ School of Medicine
Atlanta, Georgia, 30303
Med College of Georgia
Augusta, Georgia, 30912
Univ of Maryland / Inst of Human Virology
Baltimore, Maryland, 212011192
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
New England Med Ctr
Boston, Massachusetts, 02111
Univ Hosp
Boston, Massachusetts, 02118
Northwestern Univ Med School
Chicago, Illinois, 60611
Cincinnati Veterans Adm Med Ctr / Univ Hosp
Cincinnati, Ohio, 452670405
DeKalb Gen Hosp
Decatur, Georgia, 30033
Shallowford Hosp
Decatur, Georgia, 30033
Harper Hosp
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Univ of Florida College of Medicine
Gainesville, Florida, 32610
Univ TX Galveston Med Branch
Galveston, Texas, 77550
Jewish Hosp Ctr Affiliation
Jamaica, New York, 11432
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300
Dr Richard Meyer
Los Angeles, California, 90048
Cabrini Med Ctr
New York, New York, 10003
Chelsea Village Med Ctr
New York, New York, 10014
Columbia Univ
New York, New York, 10032
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
Saint Michael's Med Ctr
Newark, New Jersey, 07102
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107
Dr Michael Bach
Portland, Maine, 04102
Richmond AIDS Consortium
Richmond, Virginia, 23219
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284
Davies Med Ctr
San Francisco, California, 94114
CHG-118 Group Health / Cooperative of Puget Sound
Seattle, Washington, 98112
Dr Paul Rothman
Sherman Oaks, California, 91403
Dr Philip C Craven
Tacoma, Washington, 98405
Univ of South Florida
Tampa, Florida, 33612
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85724
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899
Bowman Gray School of Medicine / North Carolina Baptist Hosp
Winston-Salem, North Carolina, 27103
About this study
To compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Fluconazole, Amphotericin B
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B
- Medical subject headings
- Meningitis, Cryptococcal, HIV Infections, AIDS-Related Opportunistic 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.
FluconazoleDrug
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 (2)Papers the sponsor has linked to this study.
- Other trials for Meningitis, CryptococcalStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002074
- Sponsor's protocol ID
- 012D
- Other IDs
- 056-157
- Status last verified
- May 1990
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Powderly WG, Saag MS, Cloud GA, Robinson P, Meyer RD, Jacobson JM, Graybill JR, Sugar AM, McAuliffe VJ, Follansbee SE, et al. A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group. N Engl J Med. 1992 Mar 19;326(12):793-8. doi: 10.1056/NEJM199203193261203.
PubMed 1538722Saag MS, Powderly WG, Cloud GA, Robinson P, Grieco MH, Sharkey PK, Thompson SE, Sugar AM, Tuazon CU, Fisher JF, et al. Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 9;326(2):83-9. doi: 10.1056/NEJM199201093260202.
PubMed 1727236
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
- 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
- ClinicalTrials.gov ID
- NCT00002074
- Acronym / sponsor ID
- 012D
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Meningitis, Cryptococcosis, Fluconazole, Acquired Immunodeficiency Syndrome, Amphotericin B
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (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 compare the safety and effectiveness of fluconazole and amphotericin B as maintenance treatment for preventing the relapse of cryptococcal meningitis in patients with AIDS.
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 (16 listed)
- Antivirals such as zidovudine.
- Prophylaxis (including aerosolized pentamidine) for Pneumocystis carinii pneumonia (PCP).
- Pfizer must be notified if the patient is receiving ganciclovir (DHPG) at entry.
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must be oriented to person, place, and time, and able to give written informed consent.
Key exclusion criteria (45 listed)
- Clinical evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- History of allergy or intolerance of imidazoles, azoles, or amphotericin B.
- Moderate or severe liver disease.
- Ketoconazole.
- Fluconazole.
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 |
|---|---|---|
| Fluconazole | 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.
- Background: PubMed 1538722Powderly WG, Saag MS, Cloud GA, Robinson P, Meyer RD, Jacobson JM, Graybill JR, Sugar AM, McAuliffe VJ, Follansbee SE, et al. A controlled trial of fluconazole or amphotericin B to prevent relapse of cryptococcal meningitis in patients with the acquired immunodeficiency syndrome. The NIAID AIDS Clinical Trials Group and Mycoses Study Group. N Engl J Med. 1992 Mar 19;326(12):793-8. doi: 10.1056/NEJM199203193261203.
- Background: PubMed 1727236Saag MS, Powderly WG, Cloud GA, Robinson P, Grieco MH, Sharkey PK, Thompson SE, Sugar AM, Tuazon CU, Fisher JF, et al. Comparison of amphotericin B with fluconazole in the treatment of acute AIDS-associated cryptococcal meningitis. The NIAID Mycoses Study Group and the AIDS Clinical Trials Group. N Engl J Med. 1992 Jan 9;326(2):83-9. doi: 10.1056/NEJM199201093260202.
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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.
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluconazole and Amphotericin B in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 39 sites in 2 countries.
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 16 inclusion and 45 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 39 sites in United States, Canada. 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 NCT00002074, which also lists 2 linked publications.
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.