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

Results: 757(247P, 253DD, 257AD) subjects started and 646
(226P, 2o1DD, 219AD) completed 12 weeks. Subjects were
white (77%) men (91%), mean age 41 years. 85% were on
HAART. Over 12 weeks cycle ergometry performance increased
by 2.6okJ in DD (p..... o.ooi vs P) and 2.35kJ in AD. LBM (by BIS)
increased by 4.6kg in DD and 2.7kg in AD (both p.:.o.oooi vs
P), DXA data were similar. Total and trunk fat mass (by DXA)
decreased 1.4kg and 1.1kg respectively in DD, 1.2kg and o.7kg
in AD (all p......o.oooi vs P). Net increase in body weight was
2.2kg (DD), and 1.5kg (AD) (p..... o.oooi vs P). Treatment
satisfaction scores (Q7 on BACRI) were 51.6 in P, 72.3 in DD,
65.4 in AD (p..... o.ooi vs P). Statistical differences persisted
when intent-to-treat analysis was performed. Viral load did not
change over 12 weeks. Patient withdrawal was due to toxicity
(o.9%), adverse events, principally limb pains (2.1%), patient
decision (5.4%) or other causes (6.3%).
Conclusions: r-hGH (Serostim~) treatment was safe and well
tolerated. It was effective in improving physical performance,
increasing LBM and improving quality of life in HIV+ with
wasting in the era of HAART.
Corresponding author: Svanberg, Elisabeth, 15 Chemin des
Mines, 1211 Geneva, Switzerland,
Tel: [phone], Fax: [phone],
Email: [email protected]
[LBPEB90131
Switch to atazanavir from nelfinavir associated with
cholesterol and triglyceride improvement: 12 wk results from
BMS AI424-o44
Mur h, Robert', Thiry, Alexandra', Mancini, Marco1, Pokrovsky,
Vadim2, Rozenbaum, Willy3
(United States; 2Russian Federation; 3France)
Background: Atazanavir (ATV) is a potent, safe, and effective QD
PI in Phase III development. In A1424-oo8, ATV was associated
with a lipid profile superior to nelfinavir (NFV). A1424-oo8
completers were treated with ATV/d4T/3TC in AI424-o44:
subjects on NFV switched to ATV 400oo mg; subjects on ATV
continued with ATV 400oo or 6oo mg. Changes in TC, HDL-C, fasting
LDL-C, and fasting TG were assessed at 12 wks.
Results: 346 subjects were treated. 3 ATV switch subjects
discontinued for adverse events; none for virologic failure.
*P<o.ooo, #P<o.o5 for Wk 12 vs entry
Conclusions: At 12 wks, NFV to ATV switch was associated with
TC, LDL-C, and TG reductions, HDL-C increase, and decreased %
of subjects with undesirable TC and LDL-C per NCEP. Improved
lipids of this magnitude may reduce CV risk or need for
dietary/pharmacologic interventions.
Corresponding author: Kiskorna, Michelle, 131 Morristown Rd,
Basking Ridge, NJ 07920, United States,
Tel: [phone], Fax: [phone],
Email: [email protected]

[LBPEB90141
Stavudine extended/prolonged release (XR/PRC) vs
stavudine immediate release (IR) in combination with
lamivudine and efavirenz: 48 week efficacy and safety
Baril, JG1, Pollard, RB2, Raffi, F3, Whelden, M2, Rutkiewicz,
V2, Brett-Smith, H2 (iCanada; 2United States; 3France)
Background: A multinational, randomized, double-blind, placebocontrolled study evaluated the antiviral activity, safety and
tolerability of once-daily d4T extended/prolonged release
capsules (XR/PRC) compared to the current twice-daily
formulation of d4T immediate release (IR), when used in a HAART
regimen in treatment nai've HIV-infected subjects.
Methods: Adult subjects with CD4 loo cells/lL(c/lL) (_75 c/lL if
no prior AIDS event) and HIV RNA_ 2,000 copies/mL (c/mL) were
randomized to either d4T XR/PRC or d4T IR, each in combination
with 3TC + EFV. The study had 90% power to demonstrate noninferiority based on the primary outcome of proportion with HIV
RNA <400 c/mL at 48 weeks (wks).
Results: Of 797 randomized subjects, 783 began treatment.
Median baseline HIV RNA and CD4 were 4.8 loglo c/mL and 277
c/lL, respectively. All subjects had 48 wks of follow-up (median 56
wks). Two virologic response (VR) analyses for LOQ <400 c/mL
demonstrate similarity: VR-Treated (VR-T, an ITT analysis for all
treated subjects), XR/PRC 80% vs IR 75% (XR-IR], -4.4, 95%CI -
1.5, 10.3); VR-Completers (VR-C), 91% XR/PRC vs 89% IR. Analyses
for LOQ <50 c/mL also support similarity: VR-T, XR/PRC 59% vs IR
57%; VR-C, XR/PRC 67% vs IR 67%. Mean increases in CD4 were:
XR/PRC +187 vs IR +181 c/IL. At 48 wks, 4% of subjects
discontinued therapy in each group due to an adverse event (AE).
Grade 3/4 clinical AEs occurred in 43 (11%) of XR/PRC and 41
(io%) of IR subjects. Events of hepatotoxicity, pancreatitis, or
symptomatic hyperlactatemia/lactic acidosis syndrome occurred
in a total of 3 (<1%) XR/PRC vs 7 (1.5%) IR subjects. Grade 2-4
peripheral neurologic symptoms related to therapy occurred in
3% of XR/PRC and 5% of IR subjects.
Conclusion: d4T XR/PRC is well tolerated and exhibits an
antiviral and immunologic profile similar to that of d4T IR when
used in a HAART regimen for treatment-naive patients. d4T
XR/PRC is an option when designing once daily regimens.
Corresponding author: Pugh, Meredith, Medisolutions, 41
Madison Avenue, 42nd floor, New York, NY ioolo, United
States, Tel: [phone], Fax: +i 212 894 6331,
Email: [email protected]
[LBPEB9015
Reduction of HBV DNA plasma levels after addition of
tenofovir in HBV/HIV-infected patients failing
or partially responding to lamivudine
Nfifez, Marina, Perez-Olmeda, Mayte, Diaz, Beatriz, Rios,
Pilar, Garcia-Samaniego, Javier, Gonzalez-Lahoz, Juan, Soriano,
Vincent (Spain)
Background: Treatment of hepatitis B virus (HBV) infection
with lamivudine (3TC) may not completely suppress viral
replication and often fails over time due to the development of
3TC resistance. Tenofovir Dixoproxil Fumarate (TDF) is a
nucleotide analogue reverse transcriptase inhibitor active
against HIV and both wild-type and 3TC-resistant HBV. The
anti-HBV activity of TDF was explored in HBV/HIV-coinfected
patients already under a 3TC-containing antiretroviral regimen.
Methods: All HBV/HIV-coinfected patients with detectable
HBV-DNA at the time of addition of TDF to their 3TC-containing
regimens were selected at our institution. 3TC-resistance H BV

38 Program Supplement