NCT00910806

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2009

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

May 7, 2009

Last Update Submit

April 1, 2014

Conditions

HIV Infections

Keywords

TMC207-TiDP13-C117TMC207-C110TMC207drug-drug interactionTuberculosisHIVnevirapineopen-labelPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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

    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 Outcomes (2)

  • The effect of single-dose TMC207 on the steady-state plasma concentrations of NVP will be evaluated.

    This will be determined during 18 days in treatment B

  • The short-term safety and tolerability of coadministration of single-dose TMC207 and steady-state NVP will be evaluated in HIV-1 infected patients.

    This will be determined during 15 days in treatment B

Study Arms (1)

TMC207, nevirapine

EXPERIMENTAL
Drug: TMC207; nevirapine

Interventions

TMC207; nevirapineDRUG
TMC207, nevirapine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

George, South Africa

Location

Related Publications (1)

  • Svensson EM, Dooley KE, Karlsson MO. Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection. Antimicrob Agents Chemother. 2014 Nov;58(11):6406-12. doi: 10.1128/AAC.03246-14. Epub 2014 Aug 11.

    PMID: 25114140DERIVED

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Interventions

bedaquilineNevirapine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tibotec-Virco Virology BVBA Clinical Trial

    Tibotec BVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2009

First Posted

June 1, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

ZA(1)