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

This study has been completed.
Sponsor:
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
  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: 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®)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • Minimum concentration of the analyte in plasma (Cmin) [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time curve over the dosing interval (AUCτ) [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of Cmax (Tmax) [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Oral clearance (Cl/F) [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: up to 40 days ] [ Designated as safety issue: No ]
  • Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to day 40 ] [ Designated as safety issue: No ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: up to day 39 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT02181946     History of Changes
Other Study ID Numbers: 1100.1361
Study First Received: July 2, 2014
Last Updated: July 11, 2014
Health Authority: South Africa: Department of Health

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Fluconazole
Nevirapine
14-alpha Demethylase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antifungal Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014