Continued lamivudine versus delavirdine in combination with indinavir and zidovudine or stavudine in lamivudine-experienced patients: results of Adult AIDS Clinical Trials Group protocol 370.
AIDS
; 14(11): 1553-61, 2000 Jul 28.
Article
em En
| MEDLINE
| ID: mdl-10983642
ABSTRACT
OBJECTIVE:
To compare the virologic activity of continued lamivudine (3TC) versus a switch to delavirdine (DLV) when initiating protease inhibitor therapy in nucleoside-experienced patients.DESIGN:
Randomized, open-label, multi-center study.SETTING:
Adult AIDS clinical trials units. PATIENTS Protease and non-nucleoside reverse transcriptase inhibitor-naive patients who had received 3TC plus zidovudine (ZDV), stavudine (d4T), or didanosine (ddl) for at least 24 weeks.INTERVENTIONS:
Patients with plasma HIV-1 RNA levels > 500 copies/ml who previously received d4T + 3TC or ddI + 3TC were randomized to ZDV + 3TC + indinavir (IDV) or ZDV + DLV + IDV. MAIN OUTCOMEMEASURES:
Primary endpoints were the proportion of patients with plasma HIV-1 RNA levels < or = 200 copies/ml at 24 weeks, and occurrence of serious adverse events. The proportion of patients with plasma HIV-1 RNA levels < or = 200 copies/ml at week 48 was a secondary endpoint.RESULTS:
At week 24, 58% of subjects in the ZDV + 3TC + IDV arm and 73% in the ZDV + DLV + IDV arm had plasma HIV-1 RNA levels < or = 200 copies/ml (P = 0.29). At week 48, plasma HIV-1 RNA levels were < or = 200 copies/ml in 48% and 83%, respectively (P = 0.007). Rash and hyperbilirubinemia occurred more frequently in the DLV arm than in the 3TC arm. Steady-state plasma IDV levels were higher among patients in the DLV arm as compared with the 3TC arm.CONCLUSIONS:
Substituting DLV for 3TC when adding IDV improved virologic outcome in nucleoside-experienced patients. This result might be explained, in part, by the positive effect of DLV on IDV pharmacokinetics.
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Base de dados:
MEDLINE
Assunto principal:
Zidovudina
/
Síndrome da Imunodeficiência Adquirida
/
Inibidores da Protease de HIV
/
Estavudina
/
Inibidores da Transcriptase Reversa
/
Indinavir
/
Lamivudina
/
Fármacos Anti-HIV
/
Delavirdina
Tipo de estudo:
Clinical_trials
/
Guideline
Limite:
Adult
/
Female
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2000
Tipo de documento:
Article