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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02181946
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 14, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Fluconazole Drug: Nevirapine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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®)
Study Start Date : May 2001
Actual Primary Completion Date : July 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fluconazole with and without Nevirapine Drug: Fluconazole Drug: Nevirapine

Primary Outcome Measures :
  1. Maximum concentration of the analyte in plasma (Cmax) [ Time Frame: up to day 40 ]
  2. Minimum concentration of the analyte in plasma (Cmin) [ Time Frame: up to day 40 ]
  3. Area under the plasma concentration time curve over the dosing interval (AUCτ) [ Time Frame: up to day 40 ]

Secondary Outcome Measures :
  1. Time of Cmax (Tmax) [ Time Frame: up to day 40 ]
  2. Oral clearance (Cl/F) [ Time Frame: up to day 40 ]
  3. Number of patients with adverse events [ Time Frame: up to 40 days ]
  4. Number of patients with abnormal changes in laboratory parameters [ Time Frame: up to day 40 ]
  5. Number of patients with clinically significant changes in vital signs [ Time Frame: up to day 39 ]

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

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

Responsible Party: Boehringer Ingelheim Identifier: NCT02181946     History of Changes
Other Study ID Numbers: 1100.1361
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors