Clinical Trials

MainTitle

Effects of Nevirapine on the Steady State Pharmacokinetics of Fluconazole in HIV Positive Patients

This study has been completed
Sponsor
Boehringer Ingelheim


Information provided by (Responsible Party)
Boehringer Ingelheim
ClinicalTrials.gov Identifier
NCT02181946

First received: July 2, 2014
Last updated: July 11, 2014
Last Verified: July 2014
History of Changes
Purpose

Purpose

The purpose of this study was to determine the effects of nevirapine on the steady state pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine when given in combination with fluconazole.

Condition Intervention Phase
HIV Infections

Drug : Fluconazole
Drug : Nevirapine
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study in HIV+ Patients to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Fluconazole (DIFLUCAN®)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures

  • Maximum concentration of the analyte in plasma (Cmax) [ Time Frame: up to day 40 ]
  • Minimum concentration of the analyte in plasma (Cmin) [ Time Frame: up to day 40 ]
  • Area under the plasma concentration time curve over the dosing interval (AUCτ) [ Time Frame: up to day 40 ]
Secondary Outcome Measures:
  • Time of Cmax (Tmax) [ Time Frame: up to day 40 ]
  • Oral clearance (Cl/F) [ Time Frame: up to day 40 ]
  • Number of patients with adverse events [ Time Frame: up to 40 days ]
  • Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to day 40 ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: up to day 39 ]

Enrollment: 24
Study Start Date: May 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Fluconazole with and without Nevirapine

Drug: Fluconazole
Drug: Nevirapine
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Male or female patients between the ages of 18 and 65 years who are seropositive for HIV-1 antibody by an ELISA test and confirmed by an alternative method, e.g. Western Blot
  • CD4 + cell count ≥ 100 cells/mm3
  • Patients who meet the following laboratory parameters
    • Granulocyte count > 1000 cells/mm3
    • Hemoglobin > 9.0 g/dl (men and women)
    • Platelet count > 75,000 cells/mm3
    • Alkaline phosphatase < 3.0 times the upper limit of normal
    • Aspartame Transaminase (AST) and Alanine Transaminase (ALT) < 3.0 times the upper limit of normal
    • Total bilirubin < 1.5 times the upper limit of normal
  • Female patients of childbearing potential must be willing to use a reliable form of contraception which must include a medically approved from of barrier contraception
  • Patients able to provide written informed consent and comply with study requirements


Exclusion Criteria:
  • Female patients who are pregnant or breast-feeding
  • Seated systolic blood pressure below 100 mmHg, or greater than 160 mmHg, and/or heart rate less than 50 or greater than 100 beats/min
  • History of drug allergy or known drug hypersensitivity
  • Patients receiving any investigational drug, antineoplastic agent or radiotherapy other than local skin radiotherapy treatment within 12 weeks before starting study medication
  • Patients requiring systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 28 days of study entry (Study Day 1). Such substances in these categories include: macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (e.g. itraconazole), rifabutin and phenytoin
  • Patients requiring systemic treatment with CYP3A4 (cytochrome P450 3A4) substrates such as terfenadine, astemizole, cisapride, triazolam and midazolam during the course of the trial
  • Use of protease inhibitors or non-nucleoside reverse transcriptase inhibitors within 28 days of Study Day 1 or during the trial
  • Patients with a current history of intravenous drug abuse, alcohol or substance abuse (within the last year)
  • History of any clinically important disease including hepatic, renal, cardiovascular or gastrointestinal disease
  • Patients with malabsorption, severe chronic diarrhea or patients unable to maintain
adequate oral intake

contacts and locations

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181946

Sponsors and Collaborators

Boehringer Ingelheim
More Information

More Information


Responsible Party: Boehringer Ingelheim  
ClinicalTrials.gov Identifier: NCT02181946   History of Changes  
Other Study ID Numbers: 1100.1361  
Study First Received: July 2, 2014  
Last Updated: July 11, 2014  

Additional relevant MeSH terms:
HIV Infections
Fluconazole
Nevirapine

ClinicalTrials.gov processed this data on September 17, 2019
This information is provided by ClinicalTrials.gov.