A Phase III, randomized, double-blind trial of TMC278 25 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects - ECHO

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

• Registration Number: EUCTR2007-002646-38-SE
• Lead Sponsor: Tibotec Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-14
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

1. Male or female subjects, aged 18 years or older;
2. S (subject) with documented HIV-1 infection;
3. S has signed the ICF voluntarily;
4. S can comply with the protocol requirements;
5. S 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 inv, 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 or the biological cut-off on the screening virco®TYPE HIV-1 result;
9. S agrees not to start ART before the baseline visit;
10. S’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, incl. use of NVP for the prevention of vertical HIV transmission
2. Having documented genotypic evidence of NNRTI resistance at screening or from historical data avail. in the source docs, i.e. at least 1 of the NNRTI RAMs from follow. list:
A098G
L100I
K101E
K101P
K101Q
K103H
K103N
K103S
K103T
V106A
V106M
V108I
E138A
E138G
E138K
E138Q
E138R
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 inv., could compromise the S’s safety or adherence to CTP
6. Life expectancy < 6 months
7. S has any currently active AIDS defining illness with follow. 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 trial period
- Wasting syndrome due to HIV infection if, in the inv.’s opinion, it is not actively progressive and its treatment does not require hospitalization or compromise the s’s safety or compliance to adhere to CTP procedures. If the S is on maintenance therapy for previously diagnosed wasting syndrome, (s)he may be eligible for the trial only if such treatment is not incl. in list of disallowed medications
- Pneumocystis Carinii Pneumonia infection that is considered cured and the acute phase ended at least 30 days ago, and for which currently no therapeutic treatment is required
- Past occurrence of cryptococcosis that is considered to be fully cured and the acute phase ended at least 30 days ago and/or for which no therapeutic treatment is required
8. Any active clinically significant disease (eg. pancreatitis, cardiac dysfunction, active and significant psychiatric disorder, clinical suspicion of adrenal insufficiency, hepatic
impairment), or findings during screening or medical history or physical examination that in the inv.’s opinion, would compromise the outcome of the trial
9. S has active tuberculosis and/or is being treated for tuberculosis at screening
10. S has known or suspected acute HIV-1 infection
11. S has one or more of follow. risk factors for QTc prolongation:
- A confirmed prolongation of QT/QTc interval, eg. repeated demonstration of QTcF 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 2nd or 3rd degree heart block
- Intraventricular conduction delay with QRS duration > 120 ms
- Bradycardia 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 Torsades de Pointes (eg. heart failure, hypokalemia, hypomagnesemia)
12. Receipt of any investigational drug or investigational vaccine within 90 days prior to first trial drug administration
13. S enrolled in other clinical trials that incl. 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 objectives of this trial. Data collected in t

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified