A Clinical Trial Comparing the Tolerability of Etravirine to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Treatment-naive HIV-1 Infected Patients (SENSE)
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ClinicalTrials.gov Identifier: NCT00903682 |
Recruitment Status
:
Completed
First Posted
: May 18, 2009
Results First Posted
: March 7, 2011
Last Update Posted
: January 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection HIV Acquired Immunodeficiency Syndrome | Drug: etravirine (ETR, TMC125) Drug: efavirenz (EFV) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 157 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase IIb, Multi-centre, Randomised, Double-blind, Active-controlled Trial Comparing the Neuropsychiatric Adverse Event Profile of Etravirine 400mg qd Versus Efavirenz 600mg qd in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in ARV Therapy-naive HIV-1 Infected Subjects |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: etravirine
etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
|
Drug: etravirine (ETR, TMC125)
400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
|
Active Comparator: efavirenz
efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
|
Drug: efavirenz (EFV)
600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
|
- Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event [ Time Frame: between baseline and 12 weeks ]Proportion of patients with at least 1 treatment-emergent Grade 1-4 Central Nervous System or psychiatric Adverse Event, observed between Baseline through Week 12 and judged by investigator to be at least possibly related to the study drug in ETR group versus EFV group. All Adverse Events were graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE grading table"). Grade 1-4 covers all severities.
- Antiviral Activity of ETR vs. EFV [ Time Frame: between baseline and week 48 ]The proportion of patients with confirmed plasma viral load <50 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)
- Antiviral Activity of ETR vs. EFV [ Time Frame: between baseline and week 48 ]The proportion of patients with confirmed plasma viral load <200 copies/mL at Week 48 as assessed by Time to Loss of Virologic Response (TLOVR)
- Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score [ Time Frame: between baseline and week 48 ]The HIV Patient Symptoms Profile measures the tolerability of HIV treatment from the patient's perspective, using 14 concept scales in maximum 84 questions. The response options include a "no" or "yes" answer to "Did symptom occur?". If "yes", there is a problem scale which ranges from 1 = "I had this symptom and it was not a problem" to 5 = "I had this symptom and it was a severe problem". A neuropsychiatric tolerability score is composed as the sum of 21 items and ranges from 0 (best) to 105 (worse). A total Tolerability score (ie, the sum of all items) ranges from 0 (best) to 420 (worse)
- Neuropsychiatric Adverse Events by Week 48 [ Time Frame: from baseline to week 48 ]The percentage of patients with at least 1 treatment emergent Grade 1 -4 neurologic or psychiatric adverse event, judged by the investigator to be at least possibly related to the study drug.
- Mean Change From Baseline in CD4+ Cell Count [ Time Frame: at baseline and week 2, 6, 12, 24, 36 and 48 ]The mean change in CD4+ cell count from baseline was calculated with a last observation carried forward method; i.e. the last observed value was carried forward, irrespective of the reason for discontinuation.
- Resistance Determinations [ Time Frame: at baseline and all subsequent visits until week 48 in case if virologic failure ]The evolution of viral genotype and phenotype was assessed by the number of patients with resistance-associated mutations emerging at the endpoint. A mutation was considered emerging if it was present at endpoint and not present at baseline or any pre-baseline assessment. (NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; RAM = resistance-associated mutation, IAS-USA = International AIDS Society - USA)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented HIV-1 infection
- In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection
- Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection
- HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)
- Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening
Exclusion Criteria:
- Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
- The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance
- Known infection with HIV-2 or with HIV-1 group O
- Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive
- Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured
- Specific grade 3 or 4 laboratory abnormalities

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903682

Study Director: | Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen-Cilag International NV |
ClinicalTrials.gov Identifier: | NCT00903682 History of Changes |
Other Study ID Numbers: |
CR015751 TMC125VIR2038 ( Other Identifier: Janssen-Cilag International NV ) 2008-008655-42 ( EudraCT Number ) |
First Posted: | May 18, 2009 Key Record Dates |
Results First Posted: | March 7, 2011 |
Last Update Posted: | January 14, 2013 |
Last Verified: | January 2013 |
Keywords provided by Janssen-Cilag International NV:
HIV Intelence etravirine ETR TMC125 Sustiva |
efavirenz EFV Non-nucleoside Reverse Transcriptase Inhibitor NNRTI treatment-naive |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases Efavirenz Reverse Transcriptase Inhibitors |
Etravirine Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |