Abstract | OBJECTIVE: DESIGN: Phase IIb randomized trial. METHODS: RESULTS: No TMC278 dose-response relationship for efficacy and safety was observed. TMC278 demonstrated potent antiviral efficacy comparable with efavirenz over 48 weeks that was sustained to week 96 (76.9-80.0% and 71.4-76.3% of TMC278-treated patients with confirmed viral load <50 copies/ml, respectively; time-to-loss of virological-response algorithm). Median increases from baseline in CD4 cell count with TMC278 at week 96 (138.0-149.0 cells/microl) were higher than at week 48 (108.0-123.0 cells/microl). All TMC278 doses were well tolerated. The incidences of the most commonly reported grade 2-4 adverse events at least possibly related to study medication, including nausea, dizziness, abnormal dreams/nightmare, dyspepsia, asthenia, rash, somnolence and vertigo, were low and lower with TMC278 than with efavirenz. Incidences of serious adverse events, grade 3 or 4 adverse events and discontinuations due to adverse events were similar among groups. CONCLUSION: All TMC278 doses demonstrated potent and sustained efficacy comparable with efavirenz in treatment-naive patients over 96 weeks. TMC278 was well tolerated with lower incidences of neurological and psychiatric adverse events, rash and lower lipid elevations than those with efavirenz. TMC278 25 mg once daily was selected for further clinical development.
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Authors | Anton L Pozniak, Javier Morales-Ramirez, Elly Katabira, Dewald Steyn, Sergio H Lupo, Mario Santoscoy, Beatriz Grinsztejn, Kiat Ruxrungtham, Laurence T Rimsky, Simon Vanveggel, Katia Boven, TMC278-C204 Study Group |
Journal | AIDS (London, England)
(AIDS)
Vol. 24
Issue 1
Pg. 55-65
(Jan 02 2010)
ISSN: 1473-5571 [Electronic] England |
PMID | 19926964
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-HIV Agents
- Nitriles
- Pyrimidines
- Reverse Transcriptase Inhibitors
- HIV Reverse Transcriptase
- Rilpivirine
|
Topics |
- Adult
- Aged
- Anti-HIV Agents
(therapeutic use)
- Dose-Response Relationship, Drug
- Drug Resistance, Viral
(drug effects)
- Female
- HIV Infections
(drug therapy, virology)
- HIV Reverse Transcriptase
(antagonists & inhibitors)
- HIV-1
- Humans
- Male
- Middle Aged
- Nitriles
(therapeutic use)
- Pyrimidines
(therapeutic use)
- Reverse Transcriptase Inhibitors
(therapeutic use)
- Rilpivirine
- Treatment Outcome
- Viral Load
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