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Abstract
PHASE IV CLINICAL TRIAL TO ACCESS THE EFFICACY AND SAFETY OF ANTIRETROVIRAL TREATMENT WITH RITONAVIR AND SAQUINAVIR (400 mg-400 mg) CONCOMITANT WITH RIFAMPICIN IN TUBERCULOSIS AND AIDS PATIENTS
V. Rolla, A. Vieira, F. Marinho, M.C. Lourenço, M.G. Morgado
Instituto de Pesquisa Clinica Evandro Chagas e Instituto Oswaldo Cruz, Fiocruz, Rio de Janeiro, Brazil
Objective: to evaluate the efficacy and safety of concomitant use of rifampicin ritonavir/saquinavir (400/400 mg bid) in the treatment of tuberculosis (TB) associated with AIDS. Methods: phase IV, open label, non-controlled clinical trial. Inclusion criteria: AIDS patients with TB diagnosis. Exclusion criteria: prior use of protease inhibitors or more than two double analogs regimens or use of other drugs that interfere with IP pharmacokinetics. Study design: Time 0: TB diagnosis and treatment with rifampicin 600 mg isoniazid 400 mg e pirazynamid 2000 mg. At day 30 CD4 counts (CD4), viral load (VL), and start of HAART with 2 nucleoside analogs and ritonavir/saquinavir (400/400 mg bid). At day 60, CV and CD4 count to evaluate initial efficacy (1 log reduction in VL). In month 7 VL (long-term response defined as VL below the level of detection, 80 copies). Results: Mean baseline CD4 counts was 165 cells/ mm3 ((162) and baseline VL was 5,35 log ((0,5). During the trial 14 patients (82%) presented adverse events (AE) related with TB treatment. Five patients abandoned the protocol because of AE associated with ARV ingestion. All others presented > 1 log reductions in baseline VL. At month 2 we observe a case of hepatotoxicity that resulted in TB and HIV treatment interruption. At month 7, 1/6 patients presented VL<80 copies. Conclusions: the initial efficacy of ritonavir/saquinavir concomitantly with rifampicin was good, although one patient achieved VL<80 copies at month 7. Hepatotoxicity was low if considering the potential of all those drugs in association.
This study was supported byBrazilian Ministry of Heath, ABBOTT and Roche Laboratories and the Ministry of Science and Thecnology (Millenio).
The 2nd IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
882
Suggested Citation
" V. Rolla, et al.
PHASE IV CLINICAL TRIAL TO ACCESS THE EFFICACY AND SAFETY OF ANTIRETROVIRAL TREATMENT WITH RITONAVIR AND SAQUINAVIR (400 mg-400 mg) CONCOMITANT WITH RIFAMPICIN IN TUBERCULOSIS AND AIDS PATIENTS.
Poster:
The 2nd IAS Conference on HIV Pathogenesis and Treatment:
Abstract no.
882"
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