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Third International CongressDrug Therapy in HIV Infection3-7 November 1996
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CAESAR STUDY: SURROGATE MARKER CHANGES IN RELATION TO CLINICAL RESPONSE
1W Rozenbaum, 2N Clumeck, 3M de Brabander, 3M Moeremans, 4L Goh on behalf of the CAESAR Coordinating Committee
1Hopital Rothschild, Paris, France, 2Hopital Saint-Pierre, Bruxelles, Belgium, 3Janssen Research Foundation, Beerse, Belgium and 4GlaxoWellcome Research and Development, UK
Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP2.2
AIDS 1996, Vol. 10 (Suppl. 2);S10
CD4 cell counts and HIV-1 RNA by PCR were measured over 28 weeks in a subset of 332 patients from France and Belgium in the CAESAR study (Placebo 85; 3TC 163 and 3TC+loviride 84). 43% of patients entered the trial on AZT monotherapy and 76% were asymptomatic. Median CD4 cell rises and viral load reduction were significantly greater in the 3TC containing arms (p<0.001, pairwise t-test). This subgroup analysis is consistent with other published data on 3TC.
| Changes from baseline in median CD4 cells/mm3 | |||
| Study medication | Placebo | 3TC | 3TC+LVR |
| Baseline median CD cells/mm3 | 160 | 161 | 160 |
| Median peak CDR rises | +6 at week 4 | +37 at week 12 | +54 at week 4 |
| Changes from median baseline log10 HIV-1 RNA counts/mm3 | |||
| Baseline median log10 HIV-1 RNA | 5.0 | 4.8 | 4.9 |
| Median peak log10 HIV- RNA reduction | -0.1 at week 2 | -1.0 at week 2 | -1.2 at week 2 |
| Median log10 HIV-1 RNA week 28 | +0.1 | -0.3 | -0.3 |
Patients entering the study on AZT monotherapy showed greater CDR rises and viral load reductions that those who entered on combination therapy. Median peak CD4 cell rises for the 3TC containing arms were in the range of 50-53 cells/mm3 with AZT monotherapy and 35-55 cells/mm3 with combination therapy as current treatment. Median peak HIV-1 RNA reductions in the 3TC containing arms were in the range of -1.3 log10 to -1.6 log10 with AZT monotherapy and -0.6 log10 to -0.9 log10 in the combination therapy as current treatment group. There was a 73% reduction in disease progression in the 3TC containing arms in the overall population of this subset. (Relative hazard of progression 0.269, CI 0.109-0.665). The observed relationship between surrogate marker changes and clinical response will be discussed.
Presenting author: W Rozenbaum
1996-11-03
OP2.2
Originally published in AIDS Volume 10, Supplement 2 and hosted with permission of the publisher Lippincott Williams & Wilkins, 250 Waterloo Road, London, SE1 8RD, UK. Tel: +44 (0)20 7981 0700 Fax: +44 (0) 7981 0701
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