Phase 2
Completed N=211
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
Human Immunodeficiency Virus Type 1
Source: ClinicalTrials.gov NCT00128830 ↗
Enrolled (actual)
211
Serious AEs
21.8%
Results posted
Apr 2013
Primary outcomePrimary: Number of Participants With Adverse Events — 195 Participants
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
195 | — |
| SECONDARY Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48 |
22; 80 | — |
| SECONDARY Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96 |
28; 72 | — |
| SECONDARY Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96 |
105; 124; 132 | — |
| SECONDARY Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192 |
69; 81; 83 | — |
| SECONDARY Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48 |
21.50 | — |
| SECONDARY Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96 |
18.50 | — |
| SECONDARY Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96 |
120.00 | — |
| SECONDARY Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192 |
149.50 | — |
| SECONDARY Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation) |
8; 7; 6; 6; 5; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who were previously randomized to an etravirine (ETR) treatment arm and have completed at least 48 weeks of treatment with ETR
- Participants who will be able to comply with the protocol requirements
- Participants general medical condition should not interfere with the assessments and the completion of the study
Exclusion Criteria
- Use of disallowed concomitant therapy unless a prior exemption had been granted
- Participant with any treatment-emergent condition or exacerbation of underlying condition during original Phase II study
- Agrees to protocol-defined use of effective contraception
- Participant with a grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis
- Participant with any grade 4 toxicity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table; with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions; grade 4 elevation of glucose in participants with pre-existing diabetes
- Participants with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] more than 1.5 or albumin less than 30g/l or bilirubin more than 2.5 x upper limit of normal)
Data sourced from ClinicalTrials.gov (NCT00128830). 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.