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Efficacy and safety of etravirine (TMC125) in patients with highly resistant HIV-1: primary 24-week analysis.
- Source :
-
AIDS (London, England) [AIDS] 2007 Mar 30; Vol. 21 (6), pp. F1-10. - Publication Year :
- 2007
-
Abstract
- Objective: TMC125-C223 is an open-label, partially blinded, randomized clinical trial to evaluate the efficacy and safety of two dosages of etravirine (TMC125), a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against wild-type and NNRTI-resistant HIV-1.<br />Design: A total of 199 patients were randomly assigned 2: 2: 1 to twice-daily etravirine 400 mg, 800 mg and control groups, respectively. The primary endpoint was a change in viral load from baseline at week 24 in the intention-to-treat population.<br />Methods: Patients had HIV-1 with genotypic resistance to approved NNRTIs and at least three primary protease inhibitor (PI) mutations. Etravirine groups received an optimized background of at least two approved antiretroviral agents [nucleoside reverse transcriptase inhibitors (NRTI) and/or lopinavir/ritonavir and/or enfuvirtide]. Control patients received optimized regimens of at least three antiretroviral agents (NRTIs or PIs and/or enfuvirtide).<br />Results: The mean change from baseline in HIV-1 RNA at week 24 was -1.04, -1.18 and -0.19 log10 copies/ml for etravirine 400 mg twice a day, 800 mg twice a day and the control group, respectively (P < 0.05 for both etravirine groups versus control). Etravirine showed no dose-related effects on safety and tolerability. No consistent pattern of neuropsychiatric symptoms was observed. There were few hepatic adverse events, and rashes were predominantly early onset and mild to moderate in severity.<br />Conclusion: Etravirine plus an optimized background significantly reduced HIV-1-RNA levels from baseline after 24 weeks in patients with substantial NNRTI and PI resistance, and demonstrated a favorable safety profile compared with control.
- Subjects :
- Adult
CD4 Lymphocyte Count
Dreams drug effects
Drug Administration Schedule
Drug Resistance, Viral
Female
Humans
Male
Middle Aged
Mood Disorders chemically induced
Mutation
Nitriles
Pyridazines adverse effects
Pyrimidines
RNA, Viral blood
Reverse Transcriptase Inhibitors adverse effects
Treatment Outcome
Viral Load
HIV Infections drug therapy
HIV-1 drug effects
HIV-1 genetics
Pyridazines administration & dosage
Reverse Transcriptase Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 0269-9370
- Volume :
- 21
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- AIDS (London, England)
- Publication Type :
- Academic Journal
- Accession number :
- 17413684
- Full Text :
- https://doi.org/10.1097/QAD.0b013e32805e8776