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

Conditions: HIV infection
MedDRA version: 9.1Level: LLTClassification code 10020161Term: HIV infection

Registration Number: EUCTR2007-002646-38-ES

Lead Sponsor: Tibotec Pharmaceuticals Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 680

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:
A098G
L100I
K101E
K101P
K101Q
K103H
K103N
K103S
K103T
V106A
V106M
V108I
E138G
E138K
E138Q
V179D
V179E
Y181C
Y181I
Y181V
Y188C
Y188H
Y188L
G190A
G190C
G190E
G190Q
G190S
G190T
P225H
F227C
M230I
M230L
P236L
K238N
K238T
Y318F
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