HIV InfectionsNCT00002438
A Study of Itraconazole in the Prevention of Histoplasmosis, a Fungal Infection, in HIV-Infected Patients
A study testing Itraconazole in people with HIV Infections and Histoplasmosis, run by Janssen, LP at 7 sites in United States.
Trial summary
To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Histoplasmosis
- What is being tested?
- Itraconazole
- How many people
- Not given
- Where
- 7 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:
- HIV infection.
- Residence in an area endemic for H. capsulatum.
- Absolute CD4 count < 150 cells/mm3.
- No current or past active histoplasmosis.
- No other active fungal infection.
- Life expectancy of at least 1 year.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
- Inability to take oral medication.
- Concurrent Medication:
- Excluded:
Show all 31Show fewer
- Systemically-active antifungals.
- Investigational drugs (expanded access drugs are acceptable).
- Rifampin.
- Rifabutin.
- Terfenadine.
- Astemizole.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- H2 blockers.
- Omeprazole.
- Continual antacids.
- Patients with the following prior conditions are excluded:
- History of intolerance to imidazole or azole compounds.
- Prior Medication:
- Excluded within 1 month prior to study entry:
- Investigational drugs (expanded access drugs are acceptable).
- Excluded within 15 days prior to study entry:
- Rifampin.
- Rifabutin.
- Terfenadine.
- Astemizole.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Infectious Diseases of Indianapolis
Indianapolis, Indiana, 46280
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, 64132
ASCC
Memphis, Tennessee, 38103
Dr Michael Threikeld
Memphis, Tennessee, 38105
Dr Mark A Pierce
Nashville, Tennessee, 37232
About this study
Official title: Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection
To assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.
- Conditions
- HIV Infections, Histoplasmosis
- Being tested
- Itraconazole
- Keywords
- Itraconazole, Histoplasmosis, Acquired Immunodeficiency Syndrome
- Medical subject headings
- HIV Infections, Histoplasmosis, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
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 HIV InfectionsStudies 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
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002438
- Sponsor's protocol ID
- 235B
- Other IDs
- MSG 28, ITR-USA-73
- 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
- Randomized Study Comparing Itraconazole to Placebo in the Prevention of Histoplasmosis in Patients With Human Immunodeficiency Virus Infection
- ClinicalTrials.gov ID
- NCT00002438
- Acronym / sponsor ID
- 235B
- Conditions
- HIV Infections, Histoplasmosis
- Keywords
- Itraconazole, Histoplasmosis, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Janssen, LPIndustry (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 assess the safety and efficacy of itraconazole versus placebo for prevention of histoplasmosis in HIV-infected patients with CD4 counts < 150 cells/mm3 who reside where histoplasmosis is endemic. To assess the safety and efficacy of itraconazole for preventing other debilitating fungal infections, such as cryptococcosis, aspergillosis, recalcitrant oropharyngeal or vaginal candidiasis, and recurrent esophageal candidiasis.
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 (7 listed)
- HIV infection.
- Residence in an area endemic for H. capsulatum.
- Absolute CD4 count < 150 cells/mm3.
- No current or past active histoplasmosis.
- No other active fungal infection.
Key exclusion criteria (31 listed)
- Life-threatening infection or malignancy other than cutaneous Kaposi's sarcoma.
- Inability to take oral medication.
- Systemically-active antifungals.
- Investigational drugs (expanded access drugs are acceptable).
- Rifampin.
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 |
|---|---|---|
| Itraconazole | 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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itraconazole in people with HIV Infections and Histoplasmosis, run by Janssen, LP at 7 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 31 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 7 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.