AEGiS-08IAC: Safety and relative antiretroviral activity of L697,L661 versus zidovudine in HIV-1 infected patients.

8th International AIDS Conference


Amsterdam, Netherlands — July 19-24, 1992

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Safety and relative antiretroviral activity of L697,L661 versus zidovudine in HIV-1 infected patients.

Int Conf AIDS 1992 Jul 19-24; 8:We47 (abstract no. WeB 1013)
Saag MS, Douglas J, Lapidus W, DeLoach LJ, Maples V, Laskin O, Massan F, Whitley R, Kappes J, Shaw G, et al; University of Alabama, Birmingham.

OBJECTIVES: To evaluate the safety and relative antiretroviral activity of a novel non-nucleoside reverse transcriptase inhibitor, L697, 661 (L661), versus standard therapy with zidovudine (ZDV).

METHODS: Sixty-three HIV-1 infected patients with CD4+ lymphocyte counts between 201 and 500 cell/mm3 and 60 with CD4 counts less than 200 were enrolled into separate 6 week double-blind clinical trials. Eligible patients were randomly assigned to one of four treatment arms: Group A, 25mg L661 po BID; Group B, 100mg L661 po TID; Group C, 500mg L661 po BID; or Group D 100mg ZDV po 5 x/day. Patients were excluded if they had significant renal, hepatic, or hematologic abnormalities. Prior therapy with ZDV was allowed, however, patients had to be off therapy for a minimum of two weeks. Clinical and laboratory assessments were performed weekly.

RESULTS: For patients in the 200-500 CD4 count study (* = mean values; # = plasma viremic patients only): TABULAR DATA, SEE ABSTRACT VOLUME. Similar findings were noted in the CD4 less than 200 study. Seven of the 94 L661 recipients experienced transaminase elevations. Otherwise no significant differences in safety or tolerability were noted. Analysis of virus susceptibility pre- and post-study (0 to 12 weeks into a maintenance phase of the study) revealed the development of resistance in 7/7 L661 recipients.

CONCLUSIONS: 1) L661 is generally well-tolerated. 2) Moderate asymptomatic transaminase elevations were noted in less than 10% of L661 recipients. 3) L661 exhibited modest antiretroviral activity but appeared no better than standard therapy with ZDV. 4) Development of significant resistance to L661 occurred rapidly, leading to termination of these two trials.

Keywords: AEGIS, Zidovudine, HIV-1, CD4 Lymphocyte Count, Anti-HIV Agents, Reverse Transcriptase Inhibitors, Double-Blind Method, Safety, HIV-1 Reverse Transcriptase, Clinical Trials, HIV Protease Inhibitors, Human, ICA8KWDaegis,zidovudine,hiv-1,cd4lymphocytecount,anti-hivagents,reversetranscriptaseinhibitors,double-blindmethod,safety,hiv-1reversetranscriptase,clinicaltrials,hivproteaseinhibitors,human,ica8
920719
WeB1013

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