Programme Supplement [International Conference on AIDS (16th: 2006: Toronto, Canada)]

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Late Breaker Abstracts

Orlando, United States, 6Hospital of the J.W. Goethe University,
Frankfurt, Germany, 'ID Consultants, PA, Charlotte, United States,
8GlaxoSmithKline, Research Triangle Park, United States
Background: Current guidelines recommend LPV/r as a preferred
PI for ART-nalve patients. No study comparing FPV/r to LPV/r in
treatment-naive patients has been reported.
Methods: A large, randomized (1:1), open-label, multicenter,
international study to assess non-inferiority (12% margin) of
FPV/r twice daily (BID) versus LPV/r BID, each administered
with the abacavir (ABC)/lamivudine (3TC) tablet once daily (QD).
Eligible subjects had HIV-1 RNA (vRNA) >1,000 copies/mL (c/mL)
(stratified < or >100,000) and any CD4+ cell count at screening.
NRTI switches for suspected ABC HSR were permitted. Protocoldefined virologic failure (VF) was failure to achieve vRNA <400
c/mL by Week (Wk) 24 or confirmed rebound >400 c/mL. Primary
endpoints were proportion of subjects with vRNA <400 c/mL at
Wk 48 [time to loss of virologic response (TLOVR)] and treatment
discontinuations due to adverse events (AEs).
Results: ITT(E) population included 878. Baseline demographics
(median age 37 years; 78% male; 58% white/Caucasian;
11% CDC Class C; vRNA 5.07 logo10 c/mL; CD4+ cell count 192
cells/mm3) were similar between arms. Seventy-seven percent
(679/878) completed the study. Incidence of ABC HSR was 6%.
Similar increases in fasting lipid values were observed for both
regimens.

1Results at Wk 48
vRNA <400 c/mL [ITT(E),
Late Breaker TLOVR]; n (%)*
Abstracts vRNA <50 c/mL [ITT(E),
TLOVR]; n (%)
Median ACD4+ from
Baseline (Q1-Q3)
VF; n (%)
Drug-Related Grade 2-4
AEs; n (%)
Treatment
Discontinuations due to
AEs; n (%)

FPV/r (N=434)
315 (73%)
285 (66%)
176 (106-281)
16 (4%)
55 (13%)
53 (12%)

LPV/r (N=444)
317 (71%)
288 (65%)
191 (124-287)
24 (5%)
46 (10%)
43 (10%)

I
I

Results/findings: Model A: 22 patients (40.7%) had test ordered;
Model B: 48 (84.2%) had test ordered; Model C: 51 (92.7%) had
test ordered. Of 22 patients in Model A with a test order, 9 (40.9%)
received results; of 48 patients in Model B with test order, 25
(52.1%) received results; of 51 patients in Model C with test order,
46 (90.2%) received results.
Conclusions: Results show that both interventional models will
likely result in higher screening rates than traditional HIV testing
models in primary care.
Impact Statements: HIV rapid testing has been shown to be
effective in conveying results. Increased rates of testing could lead
to earlier disease identification, increased treatment and reduced
morbidity/mortality. Reduced counseling intensity might free staff
resources. As the VA is the largest HIV care provider in the US,
it would be beneficial for policymakers to consider implementing
rapid testing regularly.
THLBO207
A structured treatment interruption (STI) strategy of 12
week cycles on and off ART is clinically inferior to continuous
treatment in patients with low CD4 counts before ART: a
randomisation within the DART trial
Hakim J.1, on behalf of the DART Trial Team. 'University of
Zimbabwe, Harare, Zimbabwe, Harare, Zimbabwe
Background: Intermittent ART has the potential to reduce long-term toxicity
and ART costs and improve adherence, while maintaining clinical well-being.
Methods: 3314 ART-naive adults with CD4<200 cells/mm3 from
3 sites (2 Uganda, 1 Zimbabwe) were enrolled into the DART
trial: 813 with CD4>300 after 48/72 weeks on ART (ZDV/3TC plus
TDF, ABC or NVP) were randomised to STI (12 week cycles on/off
treatment, n=408) or continuous ART (CT, n=405).
Results: At STI/CT randomisation, median age was 37 years
(range 19-67), CD4 358 cells/mm3 (300-1054); CD4 nadir was 132
(1-199), 629 (77%) were receiving TDF or ABC, and 184 (23%) NVP.
Following DSMC review, the STI/CT randomisation was terminated
on 15 March 2006 and all patients offered continuous ART. Median
follow-up at this time was 51 weeks (range 0-85): 99% of 386
person-years (PY) follow-up in CT was spent on ART, compared
with 49% of 388PY in STI. Nine (1%) patients died (4CT,5STI).
The rate of development of first new/recurrent WHO 4 events or
death was 3.2/100PY in CT (12 patients) versus 8.3 (31 patients) in
STI (HR=2.6 (95%CI 1.4-5.1), p=0.003). Oesophageal candidiasis
was the most frequent first WHO 4 event (4CT,17STI), followed
by extra-pulmonary TB (1CT,4STI), cryptococcosis (2CT,2STI)
and herpes simplex disease (1CT,2STI). Rates of grade 4 AEs
were 7.3 versus 5.9/100PY in CT and STI respectively (p=0.46):
consequently ART changes for toxicity were higher in CT than STI
(3.1 versus 0.5/100PY respectively,p=0.02).
Conclusions: Over median follow-up of 51 weeks, the majority
(92%) of STI patients were able to take ART intermittently without
developing WHO 4 events. However, the STI strategy in DART
(12 week cycles after achieving CD4>300 with 12-18 months
therapy in patients with pre-ART CD4<200) was associated with
a 2.6-fold increased rate of disease progression, and cannot
be recommended. DART continues to compare different ART
monitoring strategies.
THLBO208
Survival and causes of death, 2 years after introduction
of antiretroviral therapy in Africa: a historical cohort
comparison in Entebbe, Uganda
Munderi P.', Watera C.', Nakiyingi J.', Kasirye A.', Walker S.2,
French N.', Gilks C.4, Grosskurth H.1. 'MRC/UVRI Uganda Research
Unit on AIDS, Entebbe, Uganda, 2Medical Research Council Clinical
Trials Unit, London, United Kingdom, 'London School of Hygiene
and Tropical Medicine, London, United Kingdom, 4World Health
Organisation, Department of HIV/AIDS, Geneva, Switzerland
Background: Over 800,000 adults are taking first-line antiretroviral therapy (ART) in Africa. Evidence on effectiveness is

limited.

U'
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Pormm

*(95% CI -3.26, 5.47)
Conclusions: FPV/r + ABC/3TC is non-inferior to LPV/r + ABC/3TC
with similar virologic response at 48 weeks using TLOVR <400 and
<50 cut-offs. 95% CI around the treatment difference suggests
highly overlapping responses. Immunologic and tolerability
outcomes were also comparable.
THLBO206
Improving HIV screening with rapid testing and streamlined
counseling
Anaya H.', Asch S.2. 'United States Department of Veteran"s
Affairs, Los Angeles, United States, 2US Department of Veteran's
Affairs, Los Angeles, United States
Objectives: HIV testing is cost-effective in unselected general
medical populations, yet rates of testing among those at-risk
remain below optimal, even among those with regular primary
care. The specific aims of this project are: * To determine whether
nurse-based referral for traditional HIV counseling/testing will
improve screening rates compared to current testing procedures. *
To determine whether nurse-based rapid testing with streamlined
counseling improves screening rates more than nurse-based
referral for traditional testing and counseling alone.
Methods: A parallel-group, controlled study was conducted in
the primary/urgent care clinics of the Los Angeles VA. Eligibility
was based on same-day appointment; age (18-65); no HIV test
in past year; unknown HIV status. One hundred sixty six patients
were randomized to one of three screening models: Model A:
patients urged to discuss testing with physician (control). Model
B: nurses offered traditional counseling/testing. Model C; nurses
offered streamlined counseling/rapid testing. Interventions were
performed by nurses in addition to regular clinic duties.

XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * PROGRAMME SUPPLEMENT