Meningitis, CryptococcalNCT00002113
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
A study testing Flucytosine and Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 3 sites in United States.
Trial summary
To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS. Fluconazole and flucytosine have different mechanisms of action. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Meningitis, Cryptococcal, HIV Infections
- What is being tested?
- Flucytosine and Fluconazole
- How many people
- 64 participants
- Where
- 3 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
- Treatment for intercurrent opportunistic infection.
- Concurrent Treatment:
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- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Patients must have:
- AIDS.
- Evidence of Cryptococcal neoformans in culture or lumbar CSF OR clinical and CSF findings compatible with cryptococcal meningitis.
- No evidence of acute or chronic meningitis of any etiology other than cryptococcosis.
- Life expectancy of at least 2 weeks.
- Prior Medication:
- Allowed:
- Prior antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Relapsing on maintenance triazole therapy for cryptococcal meningitis.
- Unable to take oral medication.
- Concurrent Medication:
- Excluded:
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- Concomitant use of any antifungal agent other than study drug.
- Patients with the following prior conditions are excluded:
- History of allergy to or intolerance of imidazoles, azoles, or flucytosine.
- Prior Medication:
- Excluded:
- More than 1 mg/kg amphotericin B.
- Systemic antifungal agents within 7 days prior to study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
UCI Med Ctr
Orange, California, 92668
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
About this study
To evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Read the detailed description
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Being tested
- Flucytosine, Fluconazole
- Keywords
- Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome
- 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.
FlucytosineDrug
FluconazoleDrug
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.
- 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
- Allocation
- Randomised
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002113
- Sponsor's protocol ID
- 213A
- Other IDs
- R-0202
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Larsen RA, Bozzette SA, Jones BE, Haghighat D, Leal MA, Forthal D, Bauer M, Tilles JG, McCutchan JA, Leedom JM. Fluconazole combined with flucytosine for treatment of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1994 Oct;19(4):741-5. doi: 10.1093/clinids/19.4.741.
PubMed 7803641
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
- A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
- ClinicalTrials.gov ID
- NCT00002113
- Acronym / sponsor ID
- 213A
- Conditions
- Meningitis, Cryptococcal, HIV Infections
- Keywords
- Meningitis, Cryptococcosis, Drug Therapy, Combination, Fluconazole, Flucytosine, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- 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 evaluate and estimate the safety and efficacy of the combination of fluconazole and flucytosine as treatment for acute cryptococcal meningitis in patients with AIDS.
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Detailed description
Fluconazole and flucytosine have different mechanisms of action. Since fluconazole has not been associated with hematologic suppression and does not produce renal impairment that can result in higher serum flucytosine levels, this combination may be better tolerated than is amphotericin B plus flucytosine.
Patients in each cohort receive a lower dose of fluconazole alone or in combination with flucytosine, or a higher dose of fluconazole alone. Doses in subsequent cohorts are escalated if safety data in the previous cohort is satisfactory. Patients are evaluated weekly for the first 4 weeks and every 2 weeks thereafter. Therapy continues until 8 weeks after the CSF becomes culture negative, up to a maximum of 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Antiviral therapy (AZT, DHPG).
- Prophylaxis for Pneumocystis carinii pneumonia.
- Treatment for intercurrent opportunistic infection.
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- AIDS.
Key exclusion criteria (13 listed)
- Relapsing on maintenance triazole therapy for cryptococcal meningitis.
- Unable to take oral medication.
- Concomitant use of any antifungal agent other than study drug.
- History of allergy to or intolerance of imidazoles, azoles, or flucytosine.
- More than 1 mg/kg amphotericin B.
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 |
|---|---|---|
| Flucytosine | Drug | – |
| Fluconazole | 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 7803641Larsen RA, Bozzette SA, Jones BE, Haghighat D, Leal MA, Forthal D, Bauer M, Tilles JG, McCutchan JA, Leedom JM. Fluconazole combined with flucytosine for treatment of cryptococcal meningitis in patients with AIDS. Clin Infect Dis. 1994 Oct;19(4):741-5. doi: 10.1093/clinids/19.4.741.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flucytosine and Fluconazole in people with Meningitis, Cryptococcal and HIV Infections, run by Pfizer at 3 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 17 inclusion and 13 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 3 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 NCT00002113, 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.