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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Fluconazole

Nevirapine

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluconazole with and without Nevirapine

Arm Description

Outcomes

Primary Outcome Measures

Maximum concentration of the analyte in plasma (Cmax)

Minimum concentration of the analyte in plasma (Cmin)

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

Secondary Outcome Measures

Time of Cmax (Tmax)

Oral clearance (Cl/F)

Number of patients with adverse events

Number of patients with abnormal changes in laboratory parameters

Number of patients with clinically significant changes in vital signs

Full Information

NCT ID

NCT02181946

First Posted

July 2, 2014

Last Updated

July 11, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02181946

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

May 2001 (undefined)

Primary Completion Date

July 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluconazole with and without Nevirapine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fluconazole

Intervention Type

Drug

Intervention Name(s)

Nevirapine

Primary Outcome Measure Information:

Title

Maximum concentration of the analyte in plasma (Cmax)

Time Frame

up to day 40

Title

Minimum concentration of the analyte in plasma (Cmin)

Time Frame

up to day 40

Title

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

Time Frame

up to day 40

Secondary Outcome Measure Information:

Title

Time of Cmax (Tmax)

Time Frame

up to day 40

Title

Oral clearance (Cl/F)

Time Frame

up to day 40

Title

Number of patients with adverse events

Time Frame

up to 40 days

Title

Number of patients with abnormal changes in laboratory parameters

Time Frame

up to day 40

Title

Number of patients with clinically significant changes in vital signs

Time Frame

up to day 39

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1100/1100.1361_U02-3038.pdf

Description

Related Info

Learn more about this trial

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

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