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

NCT02181946 | Completed Phase 4

• 1 other identifier: 1100.1361
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• Maximum concentration of the analyte in plasma (Cmax)

  up to day 40

• Minimum concentration of the analyte in plasma (Cmin)

  up to day 40

• Area under the plasma concentration time curve over the dosing interval (AUCτ)

  up to day 40

Secondary Outcomes (5)

• Time of Cmax (Tmax)

  up to day 40

• Oral clearance (Cl/F)

  up to day 40

• Number of patients with adverse events

  up to 40 days

• Number of patients with abnormal changes in laboratory parameters

  up to day 40

• Number of patients with clinically significant changes in vital signs

  up to day 39

Study Arms (1)

Fluconazole with and without Nevirapine

EXPERIMENTAL

Drug: Fluconazole; Drug: Nevirapine

Interventions

Fluconazole DRUG

Fluconazole with and without Nevirapine

Nevirapine DRUG

Fluconazole with and without Nevirapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Fluconazole; Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: May 1, 2001
• Primary Completion: July 1, 2001
• Last Updated: July 14, 2014

Record last verified: 2014-07