AEGiS-13IAC: Treatments containing HIDROXIUREA vs. HAART as first line options for naive patients.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Treatments containing HIDROXIUREA vs. HAART as first line options for naive patients.

Int Conf AIDS 2000 Jul 9-14; 13:18 (abstract no.. LbOr7)

Vila J, Rodriguez CG, Maidana MM, Capurro AF
Universidad de Belgrano, Buenos Aires, Argentina. Fax: +54 11 47 84 54 00 int.2533, E-mail: invest@ub.edu.ar.

BACKGROUND: The objective of this study is to analize if the regimens with HU can be considered as first line treatments (T) for naive patients (pts.). Material and

METHODS: An open label study were developed March 1995 to April 2000. To be included the patients had to present detectable Viral Load (VL) and to comply with the clinical and laboratory controls. The anti-retroviral treatments (ARV) were: (T1):ddI 400 mg/day,d4T 60/80mg/day and HU500 mg/day,(T2):two nucleosides(ddI-d4T-lamivudine) plus a first line protease inhibitor and (T3):ddI,indinavir and HU (500-1000 mg/Kg/day). The VL and CD4 determinations were analyzed on week 24,48, and 96 through the test of proportions,adjusting the level of significance through Bonferroni formula.

RESULTS: The distribution of patients by levels of VL and CD4 were similar in the three T. The sample comprised 284 pts.: 94 in T1, 98 in T2 and 93 in T3.In week 24 T1 and T3 (89% and 81% respectively) presented the higher proportions of undetectable (U)VL pts.with no significant differences in between(p=0.127)T2 showed a lower proportion (58%) significantly lower than the proportion of T1 (p<0.0001) and T3 (p<0.0007) In week 48 the results were similar to week 24, and in week 96 practically all patients had undetectable VL. The adverse effects analyses showed that T2 in week 48 had a greater proportion of AE significantly different (p=0.0026) from T1 that presented lower proportion; T3 had intermediate values between T1 and T2 with no significant differences (p=0.45 with T2 and p=0.048 with T1). There wasn?t treatment discontinuation due to hematological AE. No pancreatitis cases were observed in any of the treatments.

CONCLUSIONS: The combinations of some ARV with (HU) are effective(T) for HIV pts. naive because of your potent anti-retroviral action, your sporadically AE compared with HAART nd your lower cost as compared to other drugs. They may be an excellent option as initial regimen,saving others drugs as second line treatments.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, Viral Load, Didanosine, Stavudine, HIV Infections, Indinavir, Lamivudine, Drug Therapy, Combination, Human, therapy, drug therapy, AIDS
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