Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.

Haas DW, Arathoon E, Thompson MA, de Jesus Pedro R, Gallant JE, Uip DE, Currier J, Noriega LM, Lewi DS, Uribe P, Benetucci L, Cahn P, Paar D, White AC, Collier AC, Ramirez-Ronda CH, Harvey C, Chung MO, Mehrotra D, Chodakewitz J, Nguyen BY, Protocol 054/069 Study Teams
AIDS. 2000 14 (13): 1973-8

PMID: 10997402 · DOI:10.1097/00002030-200009080-00013

OBJECTIVES - To compare the efficacy and safety of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine.

DESIGN - Two multicenter, open-label, randomized 24-week studies.

METHODS - Adults HIV-1 infection, HIV-1 RNA greater than 10000 copies/ml, and no prior lamivudine or protease inhibitor therapy were eligible. In a pilot study (Study A), patients received indinavir at 800 mg every 8 h, 1000 mg every 12 h, or 1200 mg every 12 h. In a subsequent study (Study B), patients received indinavir at 800 mg every 8 h or 1200 mg every 12 h. All subjects received zidovudine (300 mg) and lamivudine (150 mg) every 12 h. An intent-to-treat analysis was used.

RESULTS - In Study A, which enrolled 88 patients, neither HIV-1 RNA nor CD4 cell responses differed significantly between treatment groups at 24 weeks when corrected for multiple comparisons. Study B enrolled 433 patients, but was prematurely discontinued when interim analysis suggested greater efficacy of three-times-daily indinavir. Of the first 87 patients reaching week 24, HIV-1 RNA was less than 400 copies/ml in 91% receiving three-times-daily versus 64% receiving two-times-daily indinavir (P < 0.01).

CONCLUSION - Three-times-daily indinavir appears more efficacious than two-times-daily dosing when administered with zidovudine and lamivudine. Two-times-daily indinavir dosing should only be considered in situations characterized by favorable pharmacokinetic drug-drug interactions.

MeSH Terms (16)

Adult Anti-HIV Agents Antiretroviral Therapy, Highly Active CD4 Lymphocyte Count Drug Administration Schedule HIV-1 HIV Infections Humans Indinavir Lamivudine Pilot Projects Reverse Transcriptase Inhibitors RNA, Viral Treatment Outcome Viral Load Zidovudine

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