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Session 15 Oral Abstract Presentations
Treatment Strategies
Session Day and Time: Wednesday 11:15 am - 12:45 pm
Presentation Time: 11:15
Room: Auditorium


64
HIV-NAT 001.4: A Prospective Randomized Trial of Structured Treatment Interruption in Patients with Chronic HIV Infection
J. Ananworanich*1,2, P. Cardiello1,3, P. Srasuebkul1,2, T. Samor1,2, E. Hassink3, A. Mahanontharit1,2, T. Boonmangum1,2, W. Apateerapong1,2, A. Hill4, K. Ruxrungtham1,2,5, D. Cooper1,6, J. Lange1,3, P. Phanuphak1,2,5
1HIV Netherlands Australia Thailand Res Collaboration, Thai Red Cross AIDS Res Ctr, Bangkok; 2Thai Red Cross AIDS Res Ctr, Bangkok, Thailand; 3Intl Antiviral Therapy Eval Ctr, Amsterdam, The Netherlands; 4Roche, Welwyn, UK; 5Chulalongkorn Univ, Bangkok, Thailand; and 6Natl Ctr In HIV Epid and Clin Res (NCHECR), Univ of New South Wales, Sydney, Australia

Background: To evaluate safety, ARV use, adverse events (AE), quality of life (QOL) of Structured Treatment Interruption (STI) in Thai patients (pts).

Methods: A total 74 pts enrolled in the HIV-NAT 001 trial series (1 yr dual NRTI followed by 3 yrs PI-based HAART) were included and randomized when last CD4 > 350 c/mm3 and VL < 50 c/ml to 3 ARV arms; arm 1: continuous (cont), arm 2: CD4-guided, arm 3: wk on-wk off. At wk 0, pts in arm 2 and 3 stopped ARV. STI in arm 2 was based on CD4 of 350 or 30% drop/rise of CD4. Failure criteria in arm 1 and 3 were VL > 1000 or CD4 < 350 on ARV. All pts were on 2NRTI+SQV-SGC1600 mg/RTV100 mg qday. Primary endpoints were % of pts with AIDS/death or with CD4 > 350. Secondary endpoints were ARV use, AE, QOL, VL. Pts were followed for 48 wks. Intent-to-treat analysis was performed using last observed values. Differences between groups were analyzed using ANOVA and Kruskal Wallis tests.

Results: Baseline characteristics were similar between groups for gender (38F/36M), mean age (34 yrs) and CD4 count (644). Both pre-ARV and pre-HAART VL logs were higher in arm 2 (4.8 and 3.2) and arm 3 (4.9 and 3.4) compared to arm 1 (4.3 and 2.6), p < 0.05.

At study termination

Arm

1 (cont)

2 (CD4-guided)

3 (wk on-wk off)

N

25

23

26

Mean time after randomization (wks)

44

46

44

N of pts with treatment failure

0

N/A1

102

% pts with CD4
> 350

100

873 (20/23)

96 (25/26)

Median CD4 change

5

-1783*

 

-6

% pts with VL
< 500/< 50

100/96

1004/834

54*/35*

Median changes in TG/cholesterol (mg/dl)

34 /-8

24/-15

9.5/5.5

% Time on ARV

100

33*

59*

1 No failure criteria, 2 Two LTF, 7 VL and 1 CD4 failures, 3 12 of 23 pts were off ARV, 4 Only pts with ³ 12 wks of re-treatment (N = 12), *p < 0.05

 

There were no AIDS/deaths and no differences in AE, serum lipids and QOL in the 3 arms. One arm 2 pt had acute retroviral syndrome at wk 4. All arm 3 failures had VL < 50 after cont ARV with same NRTI+BID SQV 1000/RTV100 (median FU of 22 wks).

Conclusions: CD4-guided and wk on-wk off strategies resulted in comparable clinical, AE and QOL outcomes to cont ARV. Proportion of pts with CD4 > 350 was similar in all arms although CD4-guided treatment had the largest CD4 count decrease. CD4-guided treatment was the best ARV cost saving strategy and had similar VL outcome to cont ARV. There were high rates of VL failures in the wk on-wk off arm; however, all had VL < 50 after continuing the same ARV regimen. Previous sub-optimal ARV prior to HAART may have contributed to STI failure.