AEGiS-14IAC: Effects of a conventional and a divergent antiretroviral combination on HIV-1 DNA Level-Trianon trial (ANRS 081).

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

Effects of a conventional and a divergent antiretroviral combination on HIV-1 DNA Level-Trianon trial (ANRS 081).

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. A10046)

Morand-Joubert L, Marcellin F, Launay O, Guiramand-Hugon S, Gerard L, Flandre P, Yeni P, Aboulker JP
Saint-Antoine Hospital, Paris, France

BACKGROUND: Trianon trial compared prospectively conventional therapy (D4T/IDV/3TC, n=71) and triple divergent therapy (D4T/IDV/NVP, n=73). Patients (pts) were either naïve, or pretreated with AZT ±ddC or ddI (21%). The conventional therapy demonstrated higher activity than the divergent therapy with respectively 86% and 63% of pts <200 cp/ml at week (W) 72 (p=0.002). The current subanalysis aims to determine the effects of the 2 therapies on the change in HIV-1 DNA level and correlated factors.

METHODS: DNA level was measured using quantitative PCR based on the Amplicor HIV-1 Monitor test (Roche). DNA level was quantified in 125 pts with available PBMC samples at baseline (BL) and at W72, and also at W4, 8, 16, and 24 for 89 of them, selected at random. We used ITT analysis in all comparisons and logistic regression for predicting DNA change at W72 from covariates.

RESULTS: BL DNA level (median: 3.05 log cp/106 PBMC) was positively correlated with BL RNA level (median: 4.77 log cp/ml) (r=0.57, p<0.0001). DNA level decreased from BL to W72 in both groups: -0.54 in D4T/IDV/3TC (p <0.0001) and -0.45 in other (p <0.0001). The change was not different between the 2 groups (p= 0.17). DNA level decrease was greater in naïve than in pretreated pts (-0,55 vs -0,23, p=0.0008). DNA level change at W72 was associated with prior treatment (OR=0.38; p=0.027), and BL CD4 count (OR=2.30; p=0.020) but not with BL RNA level, BL DNA level, or with treatment. BL DNA levels and early DNA changes (from BL to W16) were similar in pts with plasma RNA levels < or > 200 cp/ml at W72. However, DNA level change from BL to W72 was higher in pts with RNA levels <200 cp/ml at W72 than in others (-0.54 and -0.28, respectively, p=0.0092).

CONCLUSIONS: Both conventional and divergent combinations showed significant decrease in DNA levels; decrease was greater in patients previously untreated, with higher BL CD4 count, and with undetectable plasma viral load at W72.

Keywords: AEGIS, Stavudine, Zidovudine, Didanosine, Lamivudine, Viral Load, CD4 Lymphocyte Count, HIV-1, Zalcitabine, Human

020707
A10046