Teira R, Santamaria JM, Camara del Mar M, Escobar A, Lopez de Munain J, Zuber Z, Munoz P, Baraia-Etxaburu J, Cisterna R; International Conference on AIDS.
Int Conf AIDS. 2000 Jul 9-14; 13: abstract no. TuPeB3219.
R. Teira, Hospital de Basurto, Seccion de Enfermedades Infecciosas, Hospital de Basurto, Avenida de Montevideo 18, 48013 Bilbao, Spain, Tel.: +34 94 400 6000, Fax: +34 94 400 6180, E-mail: rteira@hbas.osakidetza.net
Background: The relative effectiveness of Ritonavir (RTV), Saquinavir (SQV) and Indinavir (IDV) has not been compared Methods: All patients attending our HIV-clinics between december 97 and march 98 who were to start a triple combination with a protease inhibitor (PI) were offered to participate in a clinical trial. Those who accepted were randomized 1:1:1 to RTV,SQV or IDV: Indications for PI were : 1) a CD4+ cell count lower than 500/mm3; 2) an HIH-RNA plasma concentration ('HIV-RNA'p)higher than 30000 copies/ml; 3)current treatment with 1 or 2 reverse-trancriptase inhibitors (RTI); patient request. Main outcome variable was defined as the difference between 'HIV-RNA'p at baseline and at 12 months or last observed value. CD4+ cell count changes, proportion of patients with 'HIV-RNA'p below the level of assay detection and on-treatment data are also analysed. Results: 137 patients, out of 198 candidates were included. Median baseline CD4+ cell count and baseline 'HIV-RNA'p were456/mm3 and 94800 copies/ml. 30% were antiretroviral naive. 51% completed 12 months of follow-up under their allocated treatment '75% of those of assigned to SQV, 28% on RTV and 50% on IDV'; 29% were switched to a different regimen; 18% were lost to follow-up; and 2 (1.5%) died. Mean change of 'HIV-RNA'p was, on an intent-to-treat basis, 1.02 log for SQV, 0.70 for RTV and 0.72 for IDV (p = 0.40, ANOVA). Mean change of CD4+ cell count was 72 for SQV, 47 for RTV and 42 for IDV (p = 0.72, ANOVA). After 12 months of follow-up 50% of patients had reached an 'HIV-RNA'p below the level of the assay detection (48% on SQV, 53% on RTV and 50% on IDV), as compared to the intent-to-treat achievements of 37% overall, 40% on SQV, 41% on IDV and 23% on RTV. Conclusions: if differences exist in the effectiveness of RTV, SQV, and IDV, they could not be demonstrated in this pragmatic clinical trial.
Publication Types:
Keywords:
- AIDS Vaccines
- Acquired Immunodeficiency Syndrome
- Anti-HIV Agents
- CD4 Lymphocyte Count
- HIV
- HIV Infections
- HIV Protease
- HIV Protease Inhibitors
- HIV Seropositivity
- Humans
- Indinavir
- Protease Inhibitors
- Ritonavir
- Saquinavir
Other ID:
UI: 102239129
From Meeting Abstracts