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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Nevirapine (Drug); EE/NET (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Boehringer Ingelheim

Summary

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

Clinical Details

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 design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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: Number of patients with adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

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)

Locations and Contacts

Additional Information

Starting date: April 1998
Last updated: July 11, 2014

Page last updated: August 23, 2015

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