Randomized, double-blind trial comparing indinavir alone, zidovudine alone and indinavir plus zidovudine in antiretroviral therapy-naive hiv-infected individuals with CD4 cell counts between 50 and 250/mm3

Revista do Instituto de Medicina Tropical de São Paulo

David S. Lewi²  Jamal M. Suleiman¹  David E. Uip¹  Rogerio J. Pedro¹  Rosa A. Souza¹  Grace S. Suleiman¹  Conceição Accetturi²  Olavo M. Leite¹  William B. Abreu¹  Artur O. Kalichman¹  Joaquim P.p. Moraes-filho¹  Eduardo F. Motti¹  Maria Lucia C. Pecoraro¹  Mark R. Makurath¹  Michael L. Nessly¹  Randi Y. Leavitt¹ 

[1] ,UFESPSão Paulo,Brazil

关键词: Randomized study;    Double blind clinical trial;    HIV;    AIDS;    Protease inhibitors;    Indinavir;    Zidovudine;    Disease progression;    Therapy;    Clinical endpoint;   

DOI  :  10.1590/S0036-46652000000100005

来源: SciELO

【 摘 要 】

Treatment with indinavir has been shown to result in marked decreases in viral load and increases in CD4 cell counts in HIV-infected individuals. A randomized double-blind study to evaluate the efficacy of indinavir alone (800 mg q8h), zidovidine alone (200 mg q8h) or the combination was performed to evaluate progression to AIDS. 996 antiretroviral therapy-naive patients with CD4 cell counts of 50-250/mm3 were allocated to treatment. During the trial the protocol was amended to add lamivudine to the zidovudine-containing arms. The primary endpoint was time to development of an AIDS-defining illness or death. The study was terminated after a protocol-defined interim analysis demonstrated highly significant reductions in progression to a clinical event in the indinavir-containing arms, compared to the zidovudine arm (p<0.0001). Over a median follow-up of 52 weeks (up to 99 weeks), percent reductions in hazards for the indinavir plus zidovudine and indinavir groups compared to the zidovudine group were 70% and 61%, respectively. Significant reductions in HIV RNA and increases in CD4 cell counts were also seen in the indinavir-containing groups compared to the zidovudine group. Improvement in both CD4 cell count and HIV RNA were associated with reduced risk of disease progression. All three regimens were generally well tolerated.

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