AEGiS-15IAC: A randomized trial of continuous, CD4-guided and one week on - one week off HAART in 74 patients with chronic HIV infection: week 108 results.

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15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

A randomized trial of continuous, CD4-guided and one week on - one week off HAART in 74 patients with chronic HIV infection: week 108 results.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1283)

Ananworanich J, Siangphoe U, Cardiello P, Apateerapong W, Hirschel B, Mahanontharit A, Ubolyam S, Srasuebkul P, Hill A, Lange J, Cooper D, Phanuphak P, Ruxrungtham K
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Center (TRCARC), Bangkok, Thailand

BACKGROUND: To evaluate safety, ARV use, adverse events (AE), quality of life (QOL) of structured treatment interruption (STI) in Thai patients.

METHODS: 74 NRTI pre-treated patients were given 2NRTIs+SQV-HGC1600 mg/RTV100 mg qday. When the CD4 count was >350 cells/mm³ and VL<50 copies/ml they were randomized to 3 arms, for 96 weeks; Arm 1: continuous, Arm 2: CD4-guided, Arm 3: wk on - wk off. After week 96 all patients took continuous HAART for 12 weeks. CD4-guided treatment was based on CD4 of 350 cells/mm³ or 30% CD4 drop/rise. Endpoints were % patients with CD4>350 cells/mm³, VL<400 copies/ml, AIDS/death, and ARV use, AE, QOL. Intent to treat analysis except for wk 108 CD4/VL (as treat analysis) was used. Definition of treatment failures: VL>500 (VL failure), CD4<350 (CD4 failure) while on HAART.

RESULTS: Baseline data were similar between groups for gender (38F/36M), mean age (34 yrs) and CD4 count (644 cells/mm³). Pre-ARV VL log was higher in arm 2 (4.8) and arm 3 (4.9) compared to arm 1 (4.3), p<0.05. Arm 3 was prematurely terminated because of frequent VL failure (35%). Patients with failure were re-treated continuously with the same regimen and responded with a decrease of VL to< 50 copies/ml. At week 108 (STI from wk 0-96, continuous HAART from wk 96-108) [table: see text]*p<0.05, [1]CD4 failure, [2]VL failure *p<0.05, [1]CD4 failure, [2]VL failureThere were no differences in HIV-related illnesses, AE, serum lipids and QOL between arms 1 and 2. Slightly fewer patients in arm 2 had VL<400copies/ml, which was likely due to the high VL at wk 96 (median VL 4.1 log) requiring longer than 12 wks of HAART re-treatment. Conclusion In dual NRTI pre-treated patients, wk on wk off strategy had high rates of VL failure and was prematurely stopped. After 12 wks of HAART re-treatment, patients in the CD4-guided arm for 96 weeks achieved similar CD4 and VL outcome as continuous arm patients but used 45% less HAART.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, Antigens, CD4, Acquired Immunodeficiency Syndrome, CD4 Lymphocyte Count, Anti-HIV Agents, HIV-1, HIV Infections, HIV-Associated Lipodystrophy Syndrome, HIV Protease Inhibitors, HIV Antibodies, HIV, Treatment Outcome, Humans, immunology

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WeOrB1283