- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194179
Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects
July 17, 2014 updated by: Boehringer Ingelheim
Steady State Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Steady State 400 mg of Viramune® (200 mg BID), in HIV-1 Infected Subjects, an Open Label, Non Randomised, Multidose and Multistage Parallel Group Study. (ERVIR)
The objective was to establish the pharmacokinetic (PK) profile at steady state of two different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD) under fasted and fed conditions in comparison with the commercially available NVP immediate release (IR) tablet at 200 mg BID (400 mg/day).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- HIV-1 infected males or females ≥ 18 and ≤ 60 years of age
- Body mass index 18.5 to 29.9 kg/m2, inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and local legislation
- Treated with a stable Viramune® BID based regimen since at least 12 weeks prior to study entry. If however, the subject's current Viramune® treatment consists of two 200mg tablets once daily (prescribed off label), the subject is allowed to participate if he/she agrees to switch to Viramune® 200mg twice daily, 14 days before the start of Nevirapine Extended Release.
- An HIV-1 viral load of ≤ 50 c/mL at screening
Acceptable screening laboratory values that indicate adequate baseline organ function with the following exceptions:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
≤2.5 times the upper limit of normal (ULN) (DAIDS Grade 1) or
- Gamma-glutamyl transferase (GGT) <2.5 times ULN (DAIDS Grade 1)
- Willingness to abstain from alcoholic beverages for 24 hours prior to intensive pharmakokinetic sampling days
- Willingness to abstain from ingesting substances which may alter drug plasma levels by interaction with the cytochrome P450 system during the study
- Willingness to abstain from grapefruit and grapefruit juice, Seville oranges and juice, and St John's wort or milk thistle starting 14 days prior to administration of study medication until the end of the study, and
- Karnofsky performance score ≥70
Exclusion Criteria:
- Current treatment with any PI
- Participation in another trial with an investigational medicine within two months prior to Day 1 of this study
- Serum creatinine levels >1.5 times ULN at screening
- History of acute illness within 60 days prior to Day 1, which would make the subject, in the opinion of the investigator, unsuitable for the trial
- History or evidence of severe illness, malignancy or any other conditions which would make the subjects, in the opinion of the investigator, unsuitable for the trial
- Any evidence of a clinically relevant concomitant disease, including gastrointestinal, hepatic, renal disorders of clinical relevance
- Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- Chronic or relevant acute infections other than HIV-1 (e.g. hepatitis B virus (HBV), hepatitis C virus (HCV) co infection: A chronic or acute HBV infections is defined as: HBs Ag positive. Chronic or acute HCV infection is defined as: HCV Ab positive and 1 confirmed positive viral load measurement preceding study entry)
- Alcohol or substance abuse within 6 months prior to screening or during the study
- Inability to comply with protocol requirements
- Screening laboratory values <DAIDS grade 1
- All fertile males or females, and their respective partner(s) not willing to use two forms of effective contraception. A double-barrier method must be used. A double-barrier method is defined as e.g.: 1) a condom with spermicidal jelly or with a foam suppository; 2) a diaphragm with spermicide; or 3) a male condom and a diaphragm
Female of child-bearing potential who:
- Has a positive serum pregnancy test at screening,
- Is breastfeeding,
- Is planning to become pregnant, or
- Is not willing to use barrier method protection or require ethinyl estradiol administration
- Any AIDS-defining illness that is unresolved, symptomatic, or not stable on treatment for at least 12 weeks before the screening visit
- HIV-2 infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NVP XR 400 mg (KCR 25%) fasted
|
|
Experimental: NVP XR 400 mg (KCR 25%) fed
|
|
Experimental: NVP XR 400 mg (KCR 20%) fasted
|
|
Experimental: NVP XR 400 mg (KCR 20%) fed
|
|
Experimental: NVP XR 300 mg (KCR 25%) fasted
|
|
Experimental: NVP XR 300 mg (KCR 25%) fed
|
|
Experimental: NVP XR 300 mg (KCR 20%) fasted
|
|
Experimental: NVP XR 300 mg (KCR 20%) fed
|
|
Active Comparator: NVP IR 200 mg (Viramune®)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over the time dosing interval τ)
Time Frame: up to day 22
|
up to day 22
|
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time Frame: up to day 22
|
up to day 22
|
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time Frame: up to day 22
|
up to day 22
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax,ss / Cmin,ss ratio
Time Frame: up to day 22
|
up to day 22
|
%PTF (percentage peak-trough fluctuation)
Time Frame: up to day 22
|
up to day 22
|
tmax,ss (time from dosing to the maximum concentration of the analyte in plasma at steady state over the time dosing interval τ)
Time Frame: up to day 22
|
up to day 22
|
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state)
Time Frame: up to day 22
|
up to day 22
|
Cavg (average measured concentration of the analyte in plasma at steady state)
Time Frame: up to day 22
|
up to day 22
|
Number of patients with adverse events (AEs)
Time Frame: up to day 57
|
up to day 57
|
Number of patients with clinically relevant changes in clinical laboratory tests
Time Frame: Baseline, up to day 37
|
Baseline, up to day 37
|
Number of patients with abnormal detectable viral load
Time Frame: Baseline, up to day 37
|
Baseline, up to day 37
|
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate)
Time Frame: Baseline, up to day 37
|
Baseline, up to day 37
|
Number of patients with clinically relevant changes in 12-lead electrocardiogram (ECG)
Time Frame: Baseline, day 23
|
Baseline, day 23
|
Number of patients with clinically relevant changes in physical examination
Time Frame: Baseline, up to day 37
|
Baseline, up to day 37
|
Assessment of tolerability by the investigator on a 4-point scale
Time Frame: up to day 37
|
up to day 37
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
May 1, 2007
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
July 17, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
Other Study ID Numbers
- 1100.1489
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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