HIV InfectionsPhase 4NCT02181946
Effects of Nevirapine on the Steady State Pharmacokinetics of Fluconazole in HIV Positive Patients
A Phase 4 study testing Fluconazole and Nevirapine in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
The purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fluconazole and Nevirapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2001to Jul 2001
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western Blot
- CD4 + cell count ≥ 100 cells/mm3
- Patients who meet the following laboratory parameters
- Granulocyte count > 1000 cells/mm3
- Hemoglobin > 9.0 g/dl (men and women)
- Platelet count > 75,000 cells/mm3
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- Alkaline phosphatase < 3.0 times the upper limit of normal
- Aspartame Transaminase (AST) and Alanine Transaminase (ALT) < 3.0 times the upper limit of normal
- Total bilirubin < 1.5 times the upper limit of normal
- Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved from of barrier contraception
- Patients able to provide written informed consent and comply with study requirements
Who cannot join
- Female patients who are pregnant or breast-feeding
- Seated systolic blood pressure below 100 mmHg, or greater than 160 mmHg, and/or heart rate less than 50 or greater than 100 beats/min
- History of drug allergy or known drug hypersensitivity
- Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 28 days of study entry (Study Day 1). Such substances in these categories include: macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (e.g. itraconazole), rifabutin and phenytoin
- Patients requiring systemic treatment with CYP3A4 (cytochrome P450 3A4) substrates such as terfenadine, astemizole, cisapride, triazolam and midazolam during the course of the trial
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- Use of protease inhibitors or non-nucleoside reverse transcriptase inhibitors within 28 days of Study Day 1 or during the trial
- Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
- History of any clinically important disease including hepatic, renal, cardiovascular or gastrointestinal disease
- Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
About this study
Official title: An Open-label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Fluconazole (DIFLUCAN®)
The purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole.
- Conditions
- HIV Infections
- Being tested
- Fluconazole, Nevirapine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
NevirapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole with and without Nevirapine | Experimental | Not described Receives: Drug: Fluconazole; Drug: Nevirapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of the analyte in plasma (Cmax)
Measured: up to day 40
Minimum concentration of the analyte in plasma (Cmin)
Measured: up to day 40
Area under the plasma concentration time curve over the dosing interval (AUCτ)
Measured: up to day 40
Secondary outcomes (5)
Time of Cmax (Tmax)
Measured: up to day 40
Oral clearance (Cl/F)
Measured: up to day 40
Number of patients with adverse events
Measured: up to 40 days
Number of patients with abnormal changes in laboratory parameters
Measured: up to day 40
Number of patients with clinically significant changes in vital signs
Measured: up to day 39
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2001
- Primary completionJul 2001
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.
- More trials run by Boehringer IngelheimThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181946
- Sponsor's protocol ID
- 1100.1361
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Fluconazole (DIFLUCAN®)
- ClinicalTrials.gov ID
- NCT02181946
- Acronym / sponsor ID
- 1100.1361
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Jul 2001 (actual)
- First posted
- 8 Jul 2014 (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.
The purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluconazole with and without Nevirapine | Experimental | Drug: Fluconazole, Drug: Nevirapine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western Blot
- CD4 + cell count ≥ 100 cells/mm3
- Patients who meet the following laboratory parameters
- Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved from of barrier contraception
- Patients able to provide written informed consent and comply with study requirements
Key exclusion criteria (10 listed)
- Female patients who are pregnant or breast-feeding
- Seated systolic blood pressure below 100 mmHg, or greater than 160 mmHg, and/or heart rate less than 50 or greater than 100 beats/min
- History of drug allergy or known drug hypersensitivity
- Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 28 days of study entry (Study Day 1). Such substances in these categories include: macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (e.g. itraconazole), rifabutin and phenytoin
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 | Fluconazole with and without Nevirapine |
| Nevirapine | Drug | Fluconazole with and without Nevirapine |
Primary outcome
Maximum concentration of the analyte in plasma (Cmax)
Time frame: up to day 40
Minimum concentration of the analyte in plasma (Cmin)
Time frame: up to day 40
Area under the plasma concentration time curve over the dosing interval (AUCτ)
Time frame: up to day 40
5 secondary outcomes
Time of Cmax (Tmax)
Time frame: up to day 40
Oral clearance (Cl/F)
Time frame: up to day 40
Number of patients with adverse events
Time frame: up to 40 days
Number of patients with abnormal changes in laboratory parameters
Time frame: up to day 40
Number of patients with clinically significant changes in vital signs
Time frame: up to day 39
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 14 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluconazole and Nevirapine in people with HIV Infections, run by Boehringer Ingelheim.
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 11 inclusion and 10 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Maximum concentration of the analyte in plasma (Cmax) (time frame: up to day 40). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 14 Jul 2014.