Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Nevirapine
EE/NET
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Female patients between the ages of 18 and 65 years
- Plasma HIV-1 RNA <= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
- Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³ within 28 days prior to Study Day 0
Patients who meet the following laboratory parameter:
- Lymphocyte 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
- Creatinine <= 2mg/dL
- Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
- Patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines
- Patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation
Exclusion Criteria:
- Female patients who are pregnant or breast-feeding
- Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
- Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
- Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
- Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
- Patients undergoing treatment for an active infection
- Patients with hepatic insufficiency due to cirrhosis
- Patients with renal insufficiency
- Patients who are heavy smokers (e.g. > 20 cigarettes per day)
- Patients currently taking Norvir® (Ritonavir) or Rescriptor® (Delavirdine)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nevirapine tablets
EE/NET tablets
Arm Description
once a day (q.d.) Day 2-15, twice a day (b.i.d.) Study day 16-30
Single dose on Study Day 0 and 30
Outcomes
Primary Outcome Measures
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
Cmax (maximum observed concentration) of EE/NET
Tmax (Time of maximum concentration) of EE/NET
AUCss (Area under the concentration time curve at steady state) of nevirapine
Cmax (maximum observed concentration) of nevirapine
Cmin (minimum observed concentration) of nevirapine
Cl/F (Oral clearance) of nevirapine
Secondary Outcome Measures
Number of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182791
Brief Title
Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
Official Title
An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE® ) and Ethinyl Estradiol/Norethindrone [ORTHO-NOVUM® 1/35 (21 Pack)] in HIV-1 Infected Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
April 1999 (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 treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).
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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nevirapine tablets
Arm Type
Experimental
Arm Description
once a day (q.d.) Day 2-15,
twice a day (b.i.d.) Study day 16-30
Arm Title
EE/NET tablets
Arm Type
Active Comparator
Arm Description
Single dose on Study Day 0 and 30
Intervention Type
Drug
Intervention Name(s)
Nevirapine
Intervention Type
Drug
Intervention Name(s)
EE/NET
Primary Outcome Measure Information:
Title
AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Title
Cmax (maximum observed concentration) of EE/NET
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Title
Tmax (Time of maximum concentration) of EE/NET
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
Title
AUCss (Area under the concentration time curve at steady state) of nevirapine
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Title
Cmax (maximum observed concentration) of nevirapine
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Title
Cmin (minimum observed concentration) of nevirapine
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Title
Cl/F (Oral clearance) of nevirapine
Time Frame
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Secondary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
up to 59 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients between the ages of 18 and 65 years
Plasma HIV-1 RNA <= 400 copies/mL, documenting HIV-1 infection, within 28 days prior to Study Day 0
Lymphocytes Expressing CD4+ Surface Marker (CD4+ cell count) >= 100 cells/mm³ within 28 days prior to Study Day 0
Patients who meet the following laboratory parameter:
Lymphocyte 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
Creatinine <= 2mg/dL
Female patients of reproductive potential must be willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream or jelly, or condoms with spermicidal foam)
Patients who are informed of and willing and able to comply with the investigational nature of the study and had signed a written consent in accordance with institutional and federal guidelines
Patients who have been on stable antiretroviral therapy (no changes in medication or dose) for at least thirty days prior to study entry and who will continue on background during study participation
Exclusion Criteria:
Female patients who are pregnant or breast-feeding
Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of stud entry (Study Day 0). Such substances in these categories include: macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole) rifampin, rifabutin, and phenytoin
Patients receiving any investigational drug within 30 days of the first dose of study medication and any antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
Patients with malabsorption, severe chronic diarrhea or patients unable to maintain adequate oral intake
Patients with a history of intravenous drug abuse, alcohol or substance abuse considered by the Investigator and Boehringer Ingelheim Pharmaceutical Incorporated (BIPI) Medical Monitor to be a significant impairment to health and compliance
Patients undergoing treatment for an active infection
Patients with hepatic insufficiency due to cirrhosis
Patients with renal insufficiency
Patients who are heavy smokers (e.g. > 20 cigarettes per day)
Patients currently taking Norvir® (Ritonavir) or Rescriptor® (Delavirdine)
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1245_U00-3030.pdf
Description
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Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women
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