Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02182791
First received: July 3, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: up to 59 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: April 1998
Primary Completion Date: April 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02182791     History of Changes
Other Study ID Numbers: 1100.1245
Study First Received: July 3, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Estradiol
Ethinyl Estradiol
Mestranol
Nevirapine
Norinyl
Ethynylestradiol mixture with norethindrone
Norethindrone
Norethindrone acetate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on October 01, 2014