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Clinical Trials/EUCTR2007-002646-38-ES
EUCTR2007-002646-38-ESActive, not recruitingNot Applicable

Ensayo en fase III, aleatorizado, doble ciego, TMC278 25 mg una vez al día comparado con Efavirenz 600 mg una vez al día, en combinación con una terapia de fondo fija, consistente en tenofovir disoproxil fumarato y emtricitabina, en pacientes infectados por el VIH-1, sin tratamiento antirretroviral previo. - ECHO

Tibotec Pharmaceuticals Limited0 sites680 target enrollmentStarted: November 21, 2007Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
680
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Male or female subjects, aged 18 years or older;
  • •2. Subject with documented HIV-1 infection;
  • •3. Subject has signed the ICF voluntarily;
  • •4. Subject can comply with the protocol requirements;
  • •5. Subject has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening;
  • •6. HIV-1 plasma viral load at screening is = 5,000 HIV-1 RNA copies/mL
  • •7. In the judgment of the investigator, it is appropriate to initiate ARV therapy based on the subject’s medical condition and taking into account guidelines for the treatment of HIV-1 infection;
  • •8. Demonstrated sensitivity to TDF and FTC based on results at screening or based on available historical data, when using the lower clinical cut-off (indicated as Maximal Response) or the biological cut-off (indicated as susceptible) on the screening virco®TYPE HIV-1 result;
  • •9. Subject agrees not to start ART before the baseline visit;
  • •10. Subject’s general medical condition, in the investigator’s opinion, does not interfere with the assessments and the completion of the trial.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
  • •2. Having documented genotypic evidence of NNRTI resistance at screening or from historical data available in the source documents, i.e., at least one of the NNRTI RAMs from the following list:
  • •3. Previously documented HIV-2 infection
  • •4. Use of disallowed concomitant therapy from 4 weeks prior to baseline visit
  • •5. Any condition which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the protocol
  • •6. Life expectancy less than 6 months
  • •7. Subject has any currently active AIDS defining illness with the following exceptions:
  • •- Stable, cutaneous Kaposi Sarcoma (i.e., no pulmonary or gastrointestinal involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the trial period
  • •- Wasting syndrome due to HIV infection if, in the investigator’s opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the subject’s safety or compliance to adhere to the trial protocol procedures. If the subject is on maintenance therapy for previously diagnosed wasting syndrome, he/she may be eligible for the trial only if such treatment is not included in the list of disallowed medications
  • •- Pneumocystis Carinii Pneumonia infection that is considered cured, and for which
  • •currently no therapeutic treatment is required (PCP prophylaxis is allowed, as long as it is not included in the list of disallowed medications);
  • •- Past occurrence of cryptococcosis that is considered to be fully cured and/or for which no therapeutic treatment is required
  • •8. Any active clinically significant disease (e.g., pancreatitis), or findings during screening or medical history or physical examination that in the investigator’s opinion, would compromise the outcome of the trial
  • •9. Subject has active tuberculosis and/or is being treated for tuberculosis at screening
  • •10. Subject has known or suspected acute (primary) HIV-1 infection
  • •11. Subject has one or more of the following risk factors for QTc prolongation:
  • •- A confirmed prolongation of QT/QTc interval, e.g., repeated demonstration of QTcF
  • •(Fridericia correction) interval > 450 ms in the screening ECG
  • •- Pathological Q-waves
  • •- Evidence of ventricular pre-excitation
  • •- Electrocardiographic evidence of complete or incomplete left bundle branch block or
  • •right bundle branch block
  • •- Evidence of second or third degree heart block
  • •- Intraventricular conduction delay with QRS duration > 120 ms
  • •- Bardyacardia as defined by sinus rate < 50 bpm
  • •- Personal or family history of long QT syndrome
  • •- Personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, with the exception of sinus arrhythmia
  • •- Syncopal episodes
  • •- Risk factors for torsade de points (e.g., heart failure, hypokalemia)
  • •12. Receipt of any investigational drug or investigational vaccine within 90 days prior to the first trial drug administration
  • •13. Subject enrolled in other clinical trials that include any blood sampling, specimen
  • •collection, or other interventional procedure. Concurrent participation in non-interventional observational trials is allowed as long as there is no impact on

Investigators

Sponsor
Tibotec Pharmaceuticals Limited

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