Program Supplement [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

life (QOL) by questionnaire. Non-HDL cholesterol (C) was
calculated as total C minus HDL.
Results: Of 239 pts who received treatment and follow-up (78
P, 82 DD, 79 AD), 13% were female and 20% non-caucasian.
Baseline mean age was 45 yrs, body mass index 27 kg/m2,
WC98 cm, WHR 1.o3, and VAT at L4-5 331 cm2 in men (M), 240
cm2 in women (W). At 12 wks, compared to P, VAT decreased on
DD (p<o.ool and AD (p<o.o52). On DXA, total body fat
decreased (p<o.ool, both groups) predominatly due to truncal
fat (>84%). Net weight increased <1.okg reflecting LBM gain
(p<o.ool, both groups). Mean non-HDL C, 177 mg/dl at
baseline, decreased on DD and AD (-18 and -12 mg/dl, p<.ool
and 0.oo6, respectively) compared to P. On factor analysis, the
QOL change from baseline favorable for DD (p<.oi) and 0.34 SD
unites more for AS (p<.o5) as compared to P. Treatment was
generally well-tolerated with most common adverse events
arthralgia and glycemia that was generally modest and
asymptomatic.
Conclusions: In this placebo-controlled study of r-hGH in
HARS, Serostim~ 4mg/day effectively reduced VAT and truncal
fat without weight loss, while improving QOL. Treatment also
reduced pro-atherogenic non-HDL cholesterol.
Corresponding author: Muurahainen, Norma, One Technology
Place, Rockland, MA, 2370, United States, Tel: +i 781982 9000,
Fax: [phone]o01, Email: [email protected]
LBORI9,A
Enfuvirtide (T-2o) in combination with an optimized
background (OB) regimen vs. OB alone in patients with prior
experience or resistance to each of the three classes of
approved antiretrovirals (ARVs) in Europe and Australia
Clotet, B', Lazzarin, A2, Cooper, D3, Reynes, ]4, Arasteh,
Ks, Nelson, M6, Katlama, C4, Chung, ]7, Fang, L7, Delehanty,
]7, Salgo, M7 (ISpain; 2ltaly; 3Australia; 4France; sGermany;
6United Kingdom; 7United States)
Background: Enfuvirtide (T-2o; ENF) is the most advanced
agent in a new class of investigational ARV, the Fusion
Inhibitors, that blocks gp41-mediated fusion of HIV-1 to host
cells. TORO 2 (T-2o vs Optimized Regimen Only) is the second
Phase IIll study of enfuvirtide, similar in design to TORO 1.
Methods: Patients from 64 sites in Europe and Australia with
>3 months prior experience with 3 classes of ARVs, and HIV-1
RNA >5,00ooo copies/mL selected an OB regimen of 3-5 ARVs
based on prior history and baseline (BL) genotypic (GT) and
phenotypic (PT) viral resistance. Patients were randomized 2:1
to enfuvirtide (90 mg SC BID) + OB or OB alone.
Results: 504 patients were randomized, received at least one
dose of study drug and had at least one post-BL assessment.
Median BL HIV-1 RNA in both arms was 5.1 loglo copies/mL, and
overall CD4 count 98 cells/mm3. Demographics and prior ARV
experience were balanced across arms; patients had prior
experience of an average of 12 ARVs with almost 90% of patients
having virus with 5 or more primary mutations to the 3 ARV
classes. Patients in both arms used on average 4 ARVs in their
OB regimen. At the 24 week primary analysis (ITT, Last
Observation Carried Forward) the least squared means change
from BL in viral load (covariate, phenotypic sensitivity score) were
-1.43 loglo and -0.65 loglo copies/mL for enfuvirtide + OB and
for OB alone respectively, a difference of 0.78 loglo copies/mL (p
Corresponding author: Clotet, Bonaventura, Foundation,
Hospital Germans Trias i Pujol, 08916 Badalona; Barcelona,
Spain, Spain, Tel: [phone], Fax: [phone],
Email: [email protected]

[ LBOR19B 1
Enfuvirtide (T-2o) in combination with an optimized
background (OB) regimen vs. OB alone in patients with prior
experience or resistance to each of the three classes of
approved antiretrovirals (ARVs) in North America and Brazil
Henr K', Lalezari, ]I', O'Hearn, M', Trottier, B2, Montaner,
]2, Piliero, P', Walmsley, 52, Chung, ]', Fang, L', Delehanty,
]', Salgo, M' ('United States; 2Canada)
Background: Enfuvirtide (T-2o; ENF) is an HIV fusion inhibitor,
a new class of investigational ARV that blocks gp41-mediated
fusion of HIV-1 to the host cell. TORO 1 (T-2o vs Optimized
Regimen Only) is one of two Phase Ill studies of enfuvirtide,
and is similar in design to TORO 2 performed in Europe and
Australia.
Methods: Patients from 49 sites in the USA, Canada, Mexico
and Brazil with > 6 months prior experience with 3 classes of
ARVs, and HIV-i RNA> 5,00ooo copies/mL selected an OB
regimen of 3-5 ARVs based on prior history and baseline (BL)
genotypic (GT) and phenotypic (PT) viral resistance. Patients
were randomized 2:1 to enfuvirtide (90 mg SC BID) + OB or OB
alone.
Results: 491 patients were randomized, received at least one
dose of study drug and had at least one post-BL assessment.
Median BL HIV-i RNA in both arms was 5.2 loglo copies/mL,
and overall CD4 count 80 cells/mm3. BL demographics and
prior ARV experience were balanced across treatments;
patients had prior experience with an average of 12 ARVs with
over 80% of patients having virus with 5 or more primary
mutations to the 3 ARV classes. Patients in both arms used an
average of 4 ARVs in their OB regimen. At the 24 week primary
analysis (ITT, Last Observation Carried Forward) the least
squared means of change from BL in viral load (covariate,
phenotypic sensitivity score) were -1.697 loglo copies/mL for
enfuvirtide + OB, and -0.763 loglo copies/mL for OB alone, a
difference of 0.934 loglo copies/mL (p<o.oool). By 24 weeks
11.3% and 1o.9% of patients discontinued from enfuvirtide +
OB and OB respectively. Injection site reactions (ISRs) were
experienced by 98% of patients but only 2.8% discontinued for
these. Aside from ISRs, the safety profile was comparable
across treatments and similar to previous Phase II studies.
Conclusions: Enfuvirtide provided significant viral suppression
through 24 weeks when used with an OB regimen of oral ARVs
in heavily pre-treated patients.
Corresponding author: Henry, Keith, Hennepin County Medical
Center, H IV Program mailstop #834, 701 Park Ave,
Minneapolis, MN, United States, Tel: [phone],
Fax: [phone], Email: [email protected]
[LBOR20A]
Antiretroviral strategies in nalve HIV+ subjects: comparison
of sequential 3-drug regimens (ACTG 384)
Robbins, Gregory, Shafer, Robert', Smeaton, Laura',
De Gruttola, Victor, Pettinelli, Carla', Snyder, Sally', D'Aquila,
Richard', Vella, Stefano2, Merigan, Thomas', Hirsch,
Martin', the ACTG Team, for' ('United States; 2Itoly)
Intro: 6-arm study of 980 naive Pts. 2X3 factorial design:
A. ZDV+3TC vs d4T+ddl, B. EFV vs NFV, C. 3 vs 4 drugs. This
abstract compares sequential 3-drug regimens (obj. A&B).
Design: ddl+d4T+EFV ZDV+3TC+NFV;
ddl+d4T+N FV_ZDV+3TC+EFV; ZDV+3TC+EFV ddl+d4T+N FV;
ZDV+3TC+NFV ddI+d4T+EFV (N=155/arm). NFV & EFV were
blinded. Randomization and analyses were stratified by viral

26 Program Supplement