Clinical trial NCT02182791: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: AUC (Area under the plasma concentration time curve) of ethinyl estradiol/norethindrone (EE/NET)
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
measure: Cmax (maximum observed concentration) of EE/NET
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
measure: Tmax (Time of maximum concentration) of EE/NET
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 0 and day 30
measure: AUCss (Area under the concentration time curve at steady state) of nevirapine
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
measure: Cmax (maximum observed concentration) of nevirapine
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
measure: Cmin (minimum observed concentration) of nevirapine
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
measure: Cl/F (Oral clearance) of nevirapine
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 15, 24, and 34 hours post dose on day 30
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 59 days
Other outcomes:
Locations:
Study officials:
References: