Long-term efficacy of darunavir/ritonavir monotherapy in patients with HIV-1 viral suppression: week 96 results from the MONOI ANRS 136 study

Objectives Long-term results at week 96 are needed to evaluate the capacity of the darunavir/ritonavir monotherapy strategy to maintain a sustained control of the HIV-1 viral load. Methods MONOI is a prospective, open-label, non-inferiority, randomized, 96 week trial comparing darunavir/ritonavir mo...

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Bibliographic Details
Published in:Journal of antimicrobial chemotherapy 2012-03, Vol.67 (3), p.691-695
Main Authors: Valantin, M. A., Lambert-Niclot, S., Flandre, P., Morand-Joubert, L., Cabiè, A., Meynard, J. L., Ponscarme, D., Ajana, F., Slama, L., Curjol, A., Cuzin, L., Schneider, L., Taburet, A. M., Marcelin, A. G., Katlama, C.
Format: Article
Language:English
Subjects:
Anti-HIV Agents - administration & dosage
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiretroviral drugs
Biological and medical sciences
Clinical trials
Darunavir
HIV
HIV Infections - drug therapy
HIV-1 - isolation & purification
Human immunodeficiency virus
Human immunodeficiency virus 1
Human viral diseases
Humans
Immunodeficiencies
Immunodeficiencies. Immunoglobulinopathies
Immunopathology
Infectious diseases
Medical sciences
Medical treatment
Pharmacology. Drug treatments
Prospective Studies
Ritonavir - administration & dosage
Sulfonamides - administration & dosage
Time Factors
Treatment Outcome
Viral diseases
Viral diseases of the lymphoid tissue and the blood. Aids
Viral Load
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Summary:Objectives Long-term results at week 96 are needed to evaluate the capacity of the darunavir/ritonavir monotherapy strategy to maintain a sustained control of the HIV-1 viral load. Methods MONOI is a prospective, open-label, non-inferiority, randomized, 96 week trial comparing darunavir/ritonavir monotherapy versus a darunavir/ritonavir triple-therapy strategy to maintain HIV-1 viral load suppression in HIV-1-infected patients. Clinical trial registration: NCT00412551. Results From 225 randomized patients, 219 patients reached the 48 week follow-up and 211 reached the 96 week follow-up (106 patients in the darunavir monotherapy arm and 105 in the darunavir triple-therapy arm). Baseline characteristics were well balanced between the two treatment groups. At week 96, in intent-to-treat analysis, 91/103 patients (88%, 95% CI 81-94) allocated to the darunavir/ritonavir monotherapy arm and 87/104 patients (84%, 95% CI 75-90) allocated to the darunavir triple-therapy arm achieved an HIV-1 viral load
ISSN:0305-7453
1460-2091
DOI:10.1093/jac/dkr504