HIV InfectionsPhase 3NCT00002159
A Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
A Phase 3 study testing Itraconazole and Amphotericin B in people with HIV Infections and Histoplasmosis, run by Janssen, LP at 9 sites in United States.
Trial summary
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Histoplasmosis, Blastomycosis
- What is being tested?
- Itraconazole and Amphotericin B
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 positive or negative status.
- Blastomycosis or histoplasmosis.
- Life expectancy of at least 1 week.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Liver disease.
- Self-limiting fungal disease.
- Very severe fungal disease such as meningeal involvement.
- Acute respiratory disease.
Show all 32Show fewer
- Concurrent Medication:
- Excluded at any time:
- Terfenadine.
- Astemizole.
- Oral midazolam.
- Triazolam.
- Cisapride.
- Phenytoin.
- Phenobarbital.
- Rifampin.
- Rifabutin.
- Excluded during oral consolidation:
- H2 blockers.
- Chronic antacids.
- Omeprazole.
- Lansoprazole.
- Patients with the following prior condition are excluded:
- Hypersensitivity to azole antifungals.
- Prior Medication:
- Excluded at any time:
- More than 3 days of amphotericin B, fluconazole, or ketoconazole.
- Excluded within 2 weeks prior to study entry:
- Phenytoin.
- Phenobarbital.
- Rifampin.
- Rifabutin.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Ann Arbor Veterans Administration Med Ctr
Ann Arbor, Michigan, 48105
Division of Infectious Diseases
Atlanta, Georgia, 30303
UAB Station / Infectious Division
Birmingham, Alabama, 35294
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Community Hosp
Indianapolis, Indiana, 46218
Univ of Missouri / Division of Infectious Diseases
Kansas City, Missouri, 641082792
Infectious Diseases Association / Research Med Ctr
Kansas City, Missouri, 64132
Univ of Arkansas for Med Sciences
Little Rock, Arkansas, 72205
LSU Med Ctr / Div of Pulmonary & Critical Care Med
Shreveport, Louisiana, 71130
About this study
To assess the safety of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Read the detailed description
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.
- Conditions
- HIV Infections, Histoplasmosis, Blastomycosis
- Being tested
- Itraconazole, Amphotericin B
- Keywords
- Itraconazole, Histoplasmosis, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal
- Medical subject headings
- HIV Infections, Histoplasmosis, Blastomycosis, 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.
ItraconazoleDrug
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.
- 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 3
- Primary purpose
- Treatment
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002159
- Sponsor's protocol ID
- 254A
- Other IDs
- ITR-USA-118
- Status last verified
- Dec 1997
- 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 Randomized, Open, Comparative Multicenter Study of Initial Treatment With Intravenous Itraconazole Versus Amphotericin B Followed by Consolidation Treatment With Itraconazole Capsules in Patients With Blastomycosis or Histoplasmosis
- ClinicalTrials.gov ID
- NCT00002159
- Acronym / sponsor ID
- 254A
- Conditions
- HIV Infections, Histoplasmosis, Blastomycosis
- Keywords
- Itraconazole, Histoplasmosis, Antifungal Agents, Acquired Immunodeficiency Syndrome, Amphotericin B, AIDS-Related Complex, Blastomycosis, Antibiotics, Antifungal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- 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 of intravenous itraconazole compared to amphotericin B in HIV positive or negative persons with blastomycosis or histoplasmosis.
Detailed description
Patients are randomized to receive IV itraconazole for 2 days, then either itraconazole daily for 5 days or amphotericin B daily for 7 days. IV treatment is followed by consolidation with oral itraconazole for up to 1 year.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- HIV positive or negative status.
- Blastomycosis or histoplasmosis.
- Life expectancy of at least 1 week.
Key exclusion criteria (32 listed)
- Liver disease.
- Self-limiting fungal disease.
- Very severe fungal disease such as meningeal involvement.
- Acute respiratory disease.
- Terfenadine.
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 | – |
| 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.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Itraconazole and Amphotericin B in people with HIV Infections and Histoplasmosis, run by Janssen, LP at 9 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 4 inclusion and 32 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 9 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.