- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00910806
TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
April 1, 2014 updated by: Tibotec BVBA
A Phase I, Open-label, Single-sequence Drug-drug Interaction Trial to Investigate the Pharmacokinetic Interaction Between Steady-state Nevirapine and Single-dose TMC207 in HIV-1 Infected Subjects.
The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human immunodeficiency virus-type 1 infected patients is to investigate the potential interaction between steady-state nevirapine (NVP) 200 mg b.i.d.
(twice a day) and a single dose of 400 mg TMC207 and to explore the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body).
Study Overview
Detailed Description
TMC207 is being investigated for the treatment of M. tuberculosis (TB) infection.
This is a Phase I, open-label (both participant and investigator know the name of the assigned medication), single-sequence (all participants receive treatments in the same order) drug-drug interaction trial in human immunodeficiency virus - type 1 (HIV-1) infected patients to investigate the potential interaction between steady-state nevirapine (NVP) 200 mg b.i.d.
(twice a day) and a single dose of 400 mg TMC207.
The study medication will be taken orally.
The trial population will consist of 16 patients infected with HIV-1 virus who have not yet been treated for this infection (antiretroviral or ARV naïve) with a medical indication to start ARV therapy and electing to start treatment with NVP plus two nucleos(t)ide reverse transcriptase inhibitors (N(t)RTIs).
The primary objective is to evaluate the effect of steady-state NVP 200 mg b.i.d. on the pharmacokinetics of TMC207 and its M2 metabolite after single-dose administration of TMC207 400 mg, in HIV-1 infected patients.
The secondary objectives are to evaluate the effect of single-dose TMC207 400 mg on the steady-state plasma concentrations of NVP 200 mg b.i.d. and to evaluate the short-term safety and tolerability of coadministration of single-dose TMC207 and steady-state NVP in HIV-1 infected patients.
Prior to starting the NVP-containing regimen, patients will receive a single dose of TMC207 400 mg (Treatment A).
At least 2 but no more than 4 weeks later, NVP will be started (in combination with 2 N(t)RTIs) at the recommended dosing regimen (200 mg once daily for 2 weeks followed by 200 mg twice daily).
After 4 weeks of NVP at a dose of 200 mg b.i.d., a second single dose of TMC207 400 mg will be administered (Treatment B).Pharmacokinetic profiles over 336 hours will be determined for TMC207 and its N-monodesmethyl metabolite (M2) after administration of TMC207 400 mg alone, and in combination with steady-state NVP.
Morning predose concentrations of NVP will be determined at several time points.Safety and tolerability will be evaluated throughout the trial.
Adverse events will be recorded at every visit.
A blood and urine sample will be taken at screening, day -1, 1, 2 and 15 of treatment A and B and at both follow-up visits.
An electrocardiogram will be recorded at screening, twice on day 1 and once on day 2 and 15 of treatment A and B and at the last follow-up visit.
Vital signs will be measured at screening, on day 1, 2 and 15 of treatment A and B and at both follow-up visits.
A physical examination will be performed at screening, on day -1 of treatment A and B and at both follow-up visits.
On day 1 of treatment A and B 400 mg TMC207 (4 tablets) will be taken by mouth in the morning within 10 minutes after completion of the breakfast.
At least 2 but no more than 4 weeks after the first single dose of TMC207, NVP will be started [in combination with 2 N(t)RTIs] as 200 mg once daily for 2 weeks followed by 200 mg twice daily, orally.
After 4 weeks of NVP at a dose of 200 mg twice daily, a second single dose of TMC207 will be administered.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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George, South Africa
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented HIV-1 infection
- Antiretroviral naïve patients, for whom in the judgment of the investigator, it is appropriate to initiate NVP-containing ARV therapy at least 2 but no more than 4 weeks after the first dose of TMC207, based on the patient's medical condition and taking into account local treatment guidelines for the treatment of HIV-1 infection
- Patient agrees not to start ARV therapy until at least 2 weeks after the first dose of TMC207
- patient agrees not to change NVP and N(t)RTI therapy (including dosages) from the start of NVP treatment at 200 mg b.i.d. until Day 15 of Treatment B, unless this is medically indicated as decided by the treating physician.
Exclusion Criteria:
- Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-surgical sterilization
- Patient has any currently active AIDS defining illness
- Active tuberculosis
- Known or suspected acute HIV-1 infection
- Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, or respiratory disease.
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: TMC207, nevirapine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary objective is to evaluate the effect of steady-state NVP 200 mg twice daily on the pharmacokinetics of TMC207 and its M2 metabolite after single-dose administration of TMC207 400 mg, in HIV-1 infected patients
Time Frame: Pharmacokinetic profiles over 336 hours will be determined for TMC207 and its N-monodesmethyl metabolite (M2) after administration of TMC207 400 mg alone, and in combination with steady-state NVP.
|
Pharmacokinetic profiles over 336 hours will be determined for TMC207 and its N-monodesmethyl metabolite (M2) after administration of TMC207 400 mg alone, and in combination with steady-state NVP.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effect of single-dose TMC207 on the steady-state plasma concentrations of NVP will be evaluated.
Time Frame: This will be determined during 18 days in treatment B
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This will be determined during 18 days in treatment B
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The short-term safety and tolerability of coadministration of single-dose TMC207 and steady-state NVP will be evaluated in HIV-1 infected patients.
Time Frame: This will be determined during 15 days in treatment B
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This will be determined during 15 days in treatment B
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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.
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
June 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 7, 2009
First Submitted That Met QC Criteria
May 28, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Estimate)
April 2, 2014
Last Update Submitted That Met QC Criteria
April 1, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
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
- CR015793
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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