G. Chrysos, P. Gargalianos, E.J. Giamarellos-Bourboulis, A. Provis,
J. Stefanou, I. Zelenitsas, J. Kosmidis

Infectious Diseases Unit and 1st Dept Medicine,
Athens General Hospital, Greece.

The purpose of this study was to investigate the influence of the antiretroviral therapy (ZDV alone or in combination with ddI or ddC) on the CD4(+) lymphocyte count of HIV(+) individuals.

Eighty-seven patients were studied for 12 months, 20 of them receiving ZDV monotherapy, 26 ZDV+ddI and 36 ZDV+ddC. All HIV(+) individuals under ZDV+ddI / ddC with CD4(+) >200/μl were ZDV naïve. Individuals with CD4(+) <200/μl under ZDV+ddI / ddC received ZDV or ddI monotherapy prior initiation of any combination. CD4(+) count was evaluated at 0, 3, 6 and 12 months as follows.

Mean CD4(+) count (±SD)

CD4(+) >200/μl

Therapy	Start	3 months	6 months	12 months
ZDV	325.0 ± 88.6	229.0 ± 90.4	162.7 ± 63.7	187.8 ± 126.0
ZDV + ddI	314.7 ± 76.9	305.7 ± 121.1	expected	expected
ZDV + ddC	286.7 ± 73.6	275.0 ± 90.0	286.6 ± 111.4	282.7 ± 180.7

CD4(+) <200/μl

Therapy	Start	3 months	6 months	12 months
ZDV	106.1 ± 59.8	110.3 ± 69.6	137.4 ± 77.8	78.8 ± 80.7
ZDV + ddI	78.1 ± 80.3	94.2 ± 132.2	128.0 ± 0.9	expected
ZDV + ddC	67.7 ± 53.1	108.0 ± 124.7	89.6 ± 108.4	110.7 ± 104.1

The differences between the two combinations were not statistically significant. The decrease of CD4(+) /μl in HIV(+) individuals under ZDV monotherapy versus time was statistically significant (p<0.05). The respective changes versus time in patients under both combinations did not differ (pNS). AZT+ddC at 6 and 12 months in individuals with CD4(+) >200/μl was found superior than ZDV (p<0.01).

It is concluded that ZDV+ddI or ddC is superior to ZDV as well as that both combinations are equally effective in HIV infection independent of the initial CD4(+) cell count. Both combinations remain effective despite ZDV lack of naivety in HIV(+) individuals with CD4(+) <200/μl.