MycosesNCT00002325
A Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
A study testing Fluconazole in people with Mycoses and HIV Infections, run by Pfizer at 3 sites in United States.
Trial summary
To compare the efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mycoses, HIV Infections, Coccidioidomycosis
- What is being tested?
- Fluconazole
- How many people
- Not given
- 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
- Patients must have:
- Documented HIV infection.
- CD4 count < 250 cells/mm3.
- No active coccidioidomycosis or other fungal disease requiring systemic antifungal therapy.
- Residence in area considered to be endemic for Coccidioides immitis.
- Consent of parent or guardian if under legal age of consent.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Unable to take oral medication.
- Positive serum cryptococcal antigen.
- Concurrent Medication:
- Excluded:
Show all 12Show fewer
- Systemic antifungal therapy.
- Patients with the following prior conditions are excluded:
- History of hypersensitivity to azole or imidazole compounds.
- Prior Medication:
- Excluded:
- Systemic antifungal agents within 2 weeks prior to study entry.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
McDowell Clinic
Phoenix, Arizona, 85006
Dr Lawrence Cone
Rancho Mirage, California, 92270
Tucson Veterans Administration Med Ctr
Tucson, Arizona, 85723
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area
To compare the efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.
Read the detailed description
Patients are randomized to receive either fluconazole or placebo daily.
- Conditions
- Mycoses, HIV Infections, Coccidioidomycosis
- Being tested
- Fluconazole
- Keywords
- Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis
- Medical subject headings
- Mycoses, HIV Infections, Coccidioidomycosis, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
- Other trials for MycosesStudies 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
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002325
- Sponsor's protocol ID
- 012R
- Other IDs
- R-0266
- Status last verified
- Apr 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Double-Blind, Placebo-Controlled Study of Fluconazole in the Prevention of Active Coccidioidomycosis and Other Systemic Fungal Infections in HIV-Infected Patients Living in the Coccidioidal Endemic Area
- ClinicalTrials.gov ID
- NCT00002325
- Acronym / sponsor ID
- 012R
- Conditions
- Mycoses, HIV Infections, Coccidioidomycosis
- Keywords
- Mycoses, Fluconazole, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Coccidioidomycosis
- 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 efficacy of fluconazole versus placebo in preventing the development of active coccidioidomycosis and other systemic fungal infections among HIV-infected patients with CD4 lymphocyte counts < 250 cells/mm3 who are living in the coccidioidal endemic area.
Detailed description
Patients are randomized to receive either fluconazole or placebo daily.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV infection.
- CD4 count < 250 cells/mm3.
- No active coccidioidomycosis or other fungal disease requiring systemic antifungal therapy.
- Residence in area considered to be endemic for Coccidioides immitis.
- Consent of parent or guardian if under legal age of consent.
Key exclusion criteria (12 listed)
- Unable to take oral medication.
- Positive serum cryptococcal antigen.
- Systemic antifungal therapy.
- History of hypersensitivity to azole or imidazole compounds.
- Systemic antifungal agents within 2 weeks prior to study entry.
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 | – |
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.
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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 Fluconazole in people with Mycoses 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 6 inclusion and 12 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?
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; AzTrials last refreshed its copy on 8 Nov 2026.