Final analysis of the Trilège induction-maintenance trial: results at 18 months.
BACKGROUND
First results of Trilège demonstrated that the strategy of less intensive antiviral therapy is less effective than continuation of triple-drug therapy.


OBJECTIVE
To compare the final number of failures at month 18 and to study viral dynamics in patients experiencing a virological failure.


METHODS
Longitudinal follow-up from a randomized controlled trial.


METHODS
Forty-three AIDS clinical-trial units.


METHODS
A total of 279 HIV-1 infected adults randomized in Trilège.


METHODS
Analysis of recurrent values of HIV RNA > 500 copies/ml beyond time to virologic failure.


RESULTS
A total of 83 patients experienced virological failure by month 18; 10 in the zidovudine (ZDV) + lamivudine (3TC) + indinavir (IDV) arm, 46 in the ZDV + 3TC arm, and 27 in the ZDV + IDV arm, confirming previous results. Whatever the treatment ultimately received, 87% of patients had an HIV RNA < 500 copies/ml at month 18 with no statistical difference between randomized arms. Patients experiencing a failure in the triple-drug regimen had a greater tendency to maintain HIV RNA > 500 copies/ml beyond the time of virological failure than patients in both less intensive treatment groups who experienced failure. Lower levels of HIV RNA at failure and reinitiating of either the original triple-drug regimen or a new combination of nucleoside analogue reverse transcriptase inhibitors and protease inhibitors were associated with lower hazard ratios for developing recurrent HIV RNA > 500 copies/ml.


CONCLUSIONS
Results confirmed the failure of a less intensive regimen to maintain patients with a viral suppression (HIV RNA < 500 copies/ml). Although there is a lower incidence of failure in the triple-drug regimen, randomization to a less intensive regimen of ZDV + 3TC or ZDV + IDV was not detrimental, as treatment modification, either to the original triple regimen, or a different regimen was successful.
Flandre
Philippe
P
INSERM SC10, Hôpital Paul Brousse, 16 avenue Paull Vaillant Couturier, 94807 Villejuif cedex, France.
Raffi
François
F
Descamps
Diane
D
Calvez
Vincent
V
Peytavin
Gilles
G
Meiffredy
Vincent
V
Harel
Marine
M
Hazebrouck
Sylvie
S
Pialoux
Gilles
G
Aboulker
Jean-Pierre
JP
Brun Vezinet
Françoise
F
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D019469:Indinavir / Q000008:administration & dosage* / Q000627:therapeutic use; D019259:Lamivudine / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012367:RNA, Viral / Q000097:blood; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000008:administration & dosage* / Q000627:therapeutic use
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D012367:RNA, Viral; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019469:Indinavir