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

NCT02182791 | Completed Phase 1

• 1 other identifier: 1100.1245
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (7)

• AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30

• Cmax (maximum observed concentration) of EE/NET

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30

• Tmax (Time of maximum concentration) of EE/NET

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30

• AUCss (Area under the concentration time curve at steady state) of nevirapine

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30

• Cmax (maximum observed concentration) of nevirapine

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30

• Cmin (minimum observed concentration) of nevirapine

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30

• Cl/F (Oral clearance) of nevirapine

  0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30

Secondary Outcomes (1)

• Number of patients with adverse events

  up to 59 days

Study Arms (2)

Nevirapine tablets

EXPERIMENTAL

once a day (q.d.) Day 2-15, twice a day (b.i.d.) Study day 16-30

Drug: Nevirapine

EE/NET tablets

ACTIVE COMPARATOR

Single dose on Study Day 0 and 30

Drug: EE/NET

Interventions

Nevirapine DRUG

Nevirapine tablets

EE/NET DRUG

EE/NET tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 8, 2014
• Study Start: April 1, 1998
• Primary Completion: April 1, 1999
• Last Updated: July 14, 2014

Record last verified: 2014-07