Third International Congress Drug Therapy in HIV Infection 3-7 November 1996 Glasgow, UK

PLASMA VIREMIA IS MORE PREDICTIVE OF DISEASE PROGRESSION THAN CD4 COUNTS IN HIV INFECTED INDIVIDUALS WITH CD4 COUNTS > 500 IN A RANDOMIZED TRIAL OF IMMUNIZATION WITH rgp160

Raboud Janet, Tsoukas C, Bernard N, Djurdjev O, Cassol S, Chernoff D, Fong I, Freedman J, Gill J, Goldberg E, Lafreniere R, Lee S, Montaner J, Poon M-C, Rachlis A, Schlech W, Smith G, Szabo J, Todd, J, Thomas R, Volvovitz F
The Canadian HIV Trials Network, Canada; MicroGenesys Inc., Meriden, USA; Chiron Corp., Emeryville, USA; The Montreal General Hospital, Montreal, Quebec, Canada

Int Cong Drug Therapy HIV 1996 Nov 3-7;3:Abstract No. OP6.3
AIDS 1996, Vol. 10 (Suppl. 2);S14

The objective of this study was to compare the ability of CD4 counts and plasma HIV RNA to predict progression to a new ADI in a randomized placebo controlled trial of rgp160 (VaxSyn) in patients with CD4 counts greater than 500 cells/mm³.

278 patients were enrolled in this clinical trial; 138 on VaxSyn, 140 on placebo. Patients were randomly assigned to either VaxSyn or placebo for the first two years of follow-up; all patients received VaxSyn during the third year of the trial. Relative risks of progression to an AIDS defining illness associated with baseline CD4 count and plasma HIV RNA levels were estimated with proportional hazards models. Plasma HIV RNA was measured with Chiron's HIV-1 RNA bDNA Ultrasens test with a lower limit of detection of 500 copies/ml. The median long term follow-up was 36 months. The median CD4 count and log₁₀ plasma HIV RNA at enrollment were 662 cells/mm³ and 3.30 copies/ml. There were 11 AIDS-defining illnesses during the study period, 5 among patients on the VaxSyn treatment group and 6 among patients on the placebo group. In a multivariate Cox proportional hazards model controlling for the effect of treatment, the RR's of progressing to a new ADI or death associated with a decrease in baseline CD4 count of 100 cells/mm³ and an increase in plasma HIV RNA level of 1 log₁₀ copies/ml were 2.70 (p =.36) and 5.53 (p =.005) respectively.

In conclusion, in individuals with CD4 counts above 500 cells/mm³ who were randomized to receive VaxSyn immediately or after two years, baseline plasma HIV RNA was more predictive of progressive of disease than CD4 counts. Given the small number of AIDS defining events and the relative short follow-up of 36 months, the predictive value of plasma HIV RNA was surprisingly powerful in this cohort of healthy individuals with high CD4 counts.

Presenting author: Raboud Janet

1996-11-03
OP6.3

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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