HIV InfectionsPhase 4NCT02184078
Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients
A Phase 4 study testing Nevirapine and Rifabutin in people with HIV Infections, run by Boehringer Ingelheim.
Trial summary
Study to determine the effects of nevirapine on the steady state pharmacokinetics of rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in combination with rifabutin 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?
- Nevirapine and Rifabutin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Dec 1998
- 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
- Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³
- Patients must be taking at least 2 antiretroviral agents (with the exception of ritonavir, nelfinavir and non-nucleoside reverse transcriptase inhibitors taken continuously for at least 28 days prior to study entry (Day 0)
- Patients currently being treated with rifabutin during the screening period may be included provided that patients are receiving 300 mg once daily (or 150 mg once daily for patients concomitantly taking Zidovudine (ZDV), saquinavir or indinavir) and that there has been no change in dosing of > 25% within 28 days prior to Study Day 0
- Patients who meet the following laboratory parameter:
- Granulocyte count > 1000 cells/mm³
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- Hemoglobin > 9.0 g/dl (men and women)
- Platelet count > 75000 cells/mm3
- Alkaline Phosphatase < 3.0 times the upper limit of normal
- Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) < 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 form of barrier contraception
- Patients able to provide written 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 150 mmHg and/or heart rate less than 50 or greater than 90 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 14 days of study entry (Study Day 0). Such substances in theses categories include: macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin and phenytoin
- Use of ritonavir, nelfinavir or non-nucleoside reverse transcriptase inhibitors within 28 days of Study Day 0 or during the trial
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- Patients with clinical evidence of active tuberculosis (TB) or undergoing treatment or prophylaxis for TB
- 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
- Patients with malabsorption, severe chronic diarrhea or subject unable to maintain adequate oral intake
- Patients with no previous antiretroviral background therapy taken continuously for the 28 days prior to study entry (Day 0)
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 Rifabutin (MYCOBUTIN®)
Study to determine the effects of nevirapine on the steady state pharmacokinetics of rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in combination with rifabutin
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Rifabutin
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
RifabutinDrug
| Study group | Role | What they receive |
|---|---|---|
| single group | Experimental | Nevirapine:
Study days 15-28 dose given once a day (q.d.) Study days 29-42 dose given twice a day (b.i.d.)
Rifabutin:
Study Days 0 to 42 Receives: Drug: Nevirapine; Drug: Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss (maximum observed concentration at steady state)
Measured: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Cmin,ss (minimum observed concentration at steady state)
Measured: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Tmax,ss (Time of Cmax at steady state)
Measured: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Area under the plasma concentration time curve over the dosing interval
Measured: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
CL/F (apparent total clearance)
Measured: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Secondary outcomes (1)
Number of patient with adverse events
Measured: up to day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startOct 1998
- Primary completionDec 1998
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT02184078
- Sponsor's protocol ID
- 1100.1258
- Status last verified
- Jul 2014
- First submitted
- 8 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 Rifabutin (MYCOBUTIN®)
- ClinicalTrials.gov ID
- NCT02184078
- Acronym / sponsor ID
- 1100.1258
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 9 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.
Study to determine the effects of nevirapine on the steady state pharmacokinetics of rifabutin and to assess the steady state pharmacokinetics of nevirapine when given in combination with rifabutin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Experimental | Drug: Nevirapine, Drug: RifabutinNevirapine: Study days 15-28 dose given once a day (q.d.) Study days 29-42 dose given twice a day (b.i.d.) Rifabutin: Study Days 0 to 42 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 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
- Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³
- Patients must be taking at least 2 antiretroviral agents (with the exception of ritonavir, nelfinavir and non-nucleoside reverse transcriptase inhibitors taken continuously for at least 28 days prior to study entry (Day 0)
- Patients currently being treated with rifabutin during the screening period may be included provided that patients are receiving 300 mg once daily (or 150 mg once daily for patients concomitantly taking Zidovudine (ZDV), saquinavir or indinavir) and that there has been no change in dosing of > 25% within 28 days prior to Study Day 0
- Patients who meet the following laboratory parameter:
Key exclusion criteria (11 listed)
- Female patients who are pregnant or breast-feeding
- Seated systolic blood pressure below 100 mmHg or greater than 150 mmHg and/or heart rate less than 50 or greater than 90 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 14 days of study entry (Study Day 0). Such substances in theses categories include: macrolide antibiotics (erythromycin, clarithromycin, azithromycin) azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin 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 |
|---|---|---|
| Nevirapine | Drug | single group |
| Rifabutin | Drug | single group |
Primary outcome
Cmax,ss (maximum observed concentration at steady state)
Time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Cmin,ss (minimum observed concentration at steady state)
Time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Tmax,ss (Time of Cmax at steady state)
Time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
Area under the plasma concentration time curve over the dosing interval
Time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
CL/F (apparent total clearance)
Time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42
1 secondary outcome
Number of patient with adverse events
Time frame: up to day 43
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 Nevirapine and Rifabutin 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 13 inclusion and 11 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?
Cmax,ss (maximum observed concentration at steady state) (time frame: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose at day 14 and day 42). The study lists 5 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.