HIV InfectionsNCT00002370
Study of Itraconazole in Patients With Advanced HIV Infection
A study testing Itraconazole in people with HIV Infections, run by Janssen, LP at 1 site in United States.
Trial summary
To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced HIV disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Itraconazole
- How many people
- 36 participants
- Where
- 1 siteUnited 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry.
- Patients must have:
- Documented HIV infection.
- CD4 lymphocyte count < 300 cells/mm3.
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- No clinically significant abnormalities, elicited by history and physical examination.
- No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry.
- Negative urine screening.
- No clinically significant abnormalities of electrocardiogram.
- Prior Medication:
- Allowed:
- Antiretroviral therapy providing patient has been on a stable, unchanged regimen for 8 weeks prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days.
- Unable to swallow oral solution.
- Obesity greater than 25% of ideal body weight.
- Concurrent Medication:
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- Excluded:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
- Terfenadine.
- Astemizole.
- Cisapride.
- H2 blockers.
- Omeprazole.
- Continual antacids.
- Didanosine.
- Any medication known to affect absorption, metabolism or excretion of imidazole or azole compounds.
- Patients with the following prior symptoms and conditions are excluded:
- Previous hypersensitivity to azole antifungals.
- History of surgical procedure that may interfere with absorption of itraconazole.
- History of significant blood loss in the previous 30 days.
- Prior Medication:
- Excluded:
- Excluded within 15 days prior to study entry:
- Rifampin.
- Rifabutin.
- Phenobarbital.
- Phenytoin.
- Carbamazepine.
- Digoxin.
- Warfarin.
- Midazolam.
- Triazolam.
- Excluded within 8 weeks prior to study entry:
- Change in antiretroviral therapy.
- Risk Behavior:
- Excluded:
- Patients who chew tobacco or regularly smoke more than 10 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
United States1 site
Erie County Med Ctr / Pharmacy D
Buffalo, New York, 14215
About this study
Official title: Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
To demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced HIV disease.
Read the detailed description
Patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. Patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.
- Conditions
- HIV Infections
- Being tested
- Itraconazole
- Keywords
- Itraconazole, Administration, Oral, Antifungal Agents, Acquired Immunodeficiency Syndrome, Drug Administration Schedule
- Medical subject headings
- HIV Infections, 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
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002370
- Sponsor's protocol ID
- 254B
- Status last verified
- Aug 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
- Pharmacokinetics Study of Intravenous Itraconazole Followed by Oral Dosing at 200 Mg Twice Daily in Patients With Advanced HIV Infection
- ClinicalTrials.gov ID
- NCT00002370
- Acronym / sponsor ID
- 254B
- Conditions
- HIV Infections
- Keywords
- Itraconazole, Administration, Oral, Antifungal Agents, Acquired Immunodeficiency Syndrome, Drug Administration Schedule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 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 demonstrate a dosage regimen for intravenous itraconazole that produces a plasma concentration range comparable to that obtained after currently used oral dosages of itraconazole oral solution; and to obtain preliminary safety data in patients with advanced HIV disease.
Detailed description
Patients will receive intravenous itraconazole solution twice daily for 2 days and then once daily for five additional days. Patients then randomized to receive twice-daily or once-daily itraconazole oral solution for an additional 28 days.
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 (13 listed)
- Antiretroviral therapy providing patient has already been on a stable, unchanged regimen for 8 weeks prior to study entry.
- Documented HIV infection.
- CD4 lymphocyte count < 300 cells/mm3.
- No clinically significant abnormalities, elicited by history and physical examination.
- No clinically significant abnormalities in blood count, biochemical profile, or urinalysis within 2 weeks of study entry.
Key exclusion criteria (45 listed)
- Acute opportunistic infection or other significant concurrent illness that would preclude participation for the required 36 days.
- Unable to swallow oral solution.
- Obesity greater than 25% of ideal body weight.
- Rifampin.
- Rifabutin.
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.
1 site 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, run by Janssen, LP at 1 site 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 13 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 1 site 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.