Phase 2
Completed N=157
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
HIV · Acquired Immunodeficiency Syndrome
Source: ClinicalTrials.gov NCT00903682 ↗
Enrolled (actual)
157
Serious AEs
10.8%
Results posted
Mar 2011
Primary outcomePrimary: Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event — 16.5; 46.2 percentage of patients — p=<0.001
Summary
The purpose of this study is to compare the neuropsychiatric adverse event profiles of etravirine 400mg once daily versus efavirenz 600mg once daily, in combination with 2 N(t)RTIs, in approximately 150 treatment-naÃ-ve HIV-1 infected patients. Safety, tolerability and efficacy of both treatment arms will be assessed throughout the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With at Least 1 Treatment-emergent Grade 1-4 Central Nervous System or Psychiatric Adverse Event |
16.5; 46.2 | <0.001 sig |
| SECONDARY Antiviral Activity of ETR vs. EFV |
64; 62 | — |
| SECONDARY Mean Change From Baseline in Neuropsychiatric and Total Tolerabililty Score |
-0.04; -0.01; -0.04; -0.07 | — |
| SECONDARY Neuropsychiatric Adverse Events by Week 48 |
20.3; 52.6 | — |
| SECONDARY Mean Change From Baseline in CD4+ Cell Count |
69.96; 72.45; 128.14; 121.62; 143.24; 151.46 | — |
| SECONDARY Resistance Determinations |
11; 9; 0; 2; 0; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00903682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.