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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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ClinicalTrials.gov Identifier: NCT02182791
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
Study to determine the effects of nevirapine treatment on the pharmacokinetics of ethinyl estradiol (EE)/norethindrone (NET).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nevirapine Drug: EE/NET Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 1998
Actual Primary Completion Date : April 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nevirapine tablets

once a day (q.d.) Day 2-15,

twice a day (b.i.d.) Study day 16-30

 Drug: Nevirapine
Active Comparator: EE/NET tablets
Single dose on Study Day 0 and 30
 Drug: EE/NET


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 Measures :
  1. Number of patients with adverse events [ Time Frame: up to 59 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182791    
Other Study ID Numbers: 1100.1245
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers