Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Nevirapine
Rifabutin
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single group
Arm Description
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
Outcomes
Primary Outcome Measures
Cmax,ss (maximum observed concentration at steady state)
Cmin,ss (minimum observed concentration at steady state)
Tmax,ss (Time of Cmax at steady state)
Area under the plasma concentration time curve over the dosing interval
CL/F (apparent total clearance)
Secondary Outcome Measures
Number of patient with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184078
Brief Title
Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 1998 (undefined)
Primary Completion Date
December 1998 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
Rifabutin
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Number of patient with adverse events
Time Frame
up to day 43
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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)
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1258_U99-3189.pdf
Description
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Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients
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