AEGiS-15IAC: A randomized controlled trial of efavirenz 600 mg/day versus 800 mg/day in HIV-infected patients with tuberculosis to study plasma efavirenz level, virological and immunological outcomes: A preliminary result.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

A randomized controlled trial of efavirenz 600 mg/day versus 800 mg/day in HIV-infected patients with tuberculosis to study plasma efavirenz level, virological and immunological outcomes: A preliminary result.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. MoOrB1013)

Manosuthi W, Sungkanuparph S, Vibhagool A, Kiertiburanakul S, Ruxrungtham K, Prasithsirikul W, Rattanasiri S, Thakkinstian A
Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

BACKGROUND: Concomitant use of efavirenz (EFV) and rifampicin (RIF) is common for the treatment of HIV and tuberculosis (TB). The level of EFV can be reduced by RIF. The appropriate daily dosage of EFV is still unclear and lack of clinical data supported.

METHODS: HIV-infected patients with TB, receiving RIF at least one month, were randomized to receive d4T, 3TC and EFV 600 mg/day (group A) or EFV 800 mg/day (group B). Plasma EFV level was measured (at 12 hours after dosing, on day 14) by high-performance liquid chromatography. CD4 and HIV RNA were assessed at 16, 24, 36, and 48 weeks.

RESULTS: Preliminary results of 70 patients (37 in group A and 33 in group B) were analyzed. The follow-up period ranged from 16 to 36 weeks. Gender, age, body weight, BMI, site of TB, previous infections, baseline CD4, and HIV RNA were not significantly different. Mean BW and BMI in both groups were about 50 kg and 19 kg/m[2]. Medians of baseline CD4 were 29 (1, 224) cells/mm³and 46 (0, 384) cells/mm³ in group A and B, respectively. Median EFV levels were 3.97 mg/L (0.07, 12.21) and 3.39 mg/L (1.03, 21.31) in group A and B, respectively. Three patients in group A, but no patient in group B, had EFV level<1 mg/L (p = 0.347). Median time to virological success (HIV RNA<50 copies/mL) was 16 weeks in group A and 19 weeks in group B (p = 0.960). Median CD4 change from baseline to week 16 was 87.5 cells/mm³ in group A and 88.0 cells/mm³ in group B (p = 0.978). CNS toxicity was found in 13 and 11 patients in group A and B, respectively (p = 0.675). One patient in group A had to discontinue EFV.

CONCLUSIONS: This preliminary report show that proportion of patients with plasma EFV level< 1 mg/L, time to virological success, and change of CD4 between patients receiving EFV 600 and 800 mg/day were similar. EFV 600 mg/day may be suitable for the patients with BW around 50 kg. The final results of study are needed to confirm this.

Keywords: AEGIS, HIV, Acquired Immunodeficiency Syndrome, Oxazines, Tuberculosis, HIV Seropositivity, HIV Infections, Anti-HIV Agents, Stavudine, HIV Protease Inhibitors, Lamivudine, Infection, efavirenz, Humans, virology, immunology

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MoOrB1013