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

Enrollment was suspended prior to targeted accrual (630) after
the initial review by a DSMB concluded that both arms met
pre-determined criteria for futility of treatment.
Results: 86 subjects were randomized to receive P and 88 to
receive F. 170/174 subjects had available 12-week lipid data. At
week 12, 4 subjects (5%) on P achieved the NCEP composite
goal and 1 (1%) subject on F achieved goal. 30 (36%) of P
recipients met LDL goals; 8 (9%) of F subjects met LDL goal (p <
o.ooi). 41 (49%) of subjects on P met HDL goals, whereas 57
(66%) of subjects on F met HDL goal (p < 0.05). 15 (18%) of
subjects on P met TG goal, whereas 42 (48%) of subjects on F
met TG goal (p < o.ooi). Median changes in LDL/HDL/TG were -
30/o/-27 and 118 mg/dL in subjects receiving P and F,
respectively (p-values for treatment difference were all
significant). 136 subjects subsequently went on dual therapy.
Four subjects (3F, IP) discontinued therapy due to protocoldefined toxicities in the first 12 weeks. There were no reports
of rhabdomyolysis.
Conclusion: Monotherapy with either P or F for HIV-related
dyslipidemia appears safe but unlikely to achieve composite
NCEP goal. P appears to be most effective in lowering LDL,
while subjects receiving F had larger increases in HDL and
decreases in TG. Dual therapy with P and F is being evaluated
for effectiveness at achieving composite NCEP goal.
Corresponding author: Aberg, Judith, Washington University
AIDS Clinical Trials Unit, 4511 Forest Park Ave, Suite 304, Saint
Louis, MO 63108, United States,
Tel: [phone], Fax: [phone],
Email: [email protected]
[LBPEB90191
Prevaleat Study (Premature Vascular Lesions and
Antiretroviral Therapy). A color-Doppler ultrasonographic
comparative study between patients treated with PI-including
regimens vs NNRTI-including regimens
Maggi, Paolo, Fiorentino, Giuseppe, Epifani, Giuseppe, Perilli,
Francesco, Lillo, Antonio, Ladisa, Nicoletta, Ferraro,
Sergio, Gargiulo, Miriam, Chirianni, Antonio, Regina,
Guido, Pastore, Giuseppe (Italy)
Background: Several reports have indicated that HIV-positive
patients seem to have an increased risk of cardiovascular
diseases, although the role of treatment with PI remains a
controversial issue. Color doppler ultrasonographic study of
the epiaortic vessels is a safe and sensitive technique capable
to detect initial lesions of the vascular wall.
In the present study, in order to obtain a more specific
correlation between antiretroviral therapy and lesions of the
carotid vessels, we have compared PI-treated patients (group
A) with PI-nailve patients treated with a regimen including
NNRTI(group B) and with patients treated with two NRTI or
naive to antiretroviral therapy (group C)
Methods: Group A included 92 patients, group B 55 patients,
group C 60 patients. All treated patients had treatment for at
least 12 months and were evaluated for familial history of
cardiovascular disease, sedentary life, cigarette smoking,
alcohol abuse, active drug addiction and values for fasting
glycemia, cholesterolemia and triglyceridemia. Intima
characteristics, pulsation and resistance indexes, minimal,
peak and mean speed were evaluated using an AU5 ESAOTE
color power doppler. Atherosclerotic plaques were described.
Results: In group A 53 patients (57.6%) showed acquired
lesions of the vascular wall, whereas similar lesions were
found in only 7 patients (12.7%) in group B. In group C, nine

cases (15%) of acquired lesions were evidenced. At statistical
analysis, cigarette smoking, hypertriglyceridemia and CDC
stage significantly increased the risk of vascular lesions.
However, the highest significance regarded use of PI.
Conclusions: These data in our ongoing study show an higher
prevalence of acquired carotid lesions even when compared
with patients treated with NNRTI-including regimens. No
statistical difference resulted when this latter group was
compared with patients naive or treated with two NRTI.
Corresponding author: Maggi, Paolo, Clinica Malattie Infettive
Policlinico, Piazza Giulio Cesare, 11, 70124 Bari, Italy,
Tel: [phone], Fax: [phone],
Email: [email protected]
[LBPEB90201
Pharmacodynamic effects of zidovudine 6oo mg once daily
versus zidovudine 300 mg twice daily in therapy-naive
HIV-infected patients (COD200ooo2)
Ruane, Peter, Richmond, Gary, Edwin, Dejesus, Hill-Zabala,
Christina, Danehower, Susan, Liao, Qiming, Johnson,
Judy, Shaefer, Mark (United States)
Background: Recent intracellular zidovudine (ZDV) triphosphate
data suggest that ZDV may be dosed once daily (QD). This 14-day
pharmacodynamic study compared the virologic activity of ZDV
monotherapy administered as 6oomg QD v. 3oomg BID.
Methods: Antiretroviral-nalVe subjects ( 18 years, HIV RNA
>7,500 c/mL, CD4 300 cells/mm3, no thymidine analog
mutations) were randomized to open-label monotherapy with
ZDV 6oomg Q24H (~3 hours) or 3oomg Q12H (~3 hours). HIV-1
RNA (VL) was measured daily and i dose of ZDV was observed
each day. The sample size of 16 subjects/arm provided at least
80% power to detect a 0.036 difference in the slope of VL decline
between groups over 14 days (approximately a 0.5 loglo
difference at Day 14). VL was log transformed prior to analysis.
Results: All 32 subjects (94% male, median age 34 years)
completed the 14-day study. Mean baseline (BL) VL was 4.33
and 4.40 loglo c/mL in the QD and BID arms, respectively. The
slope of VL decline from Days 1-14 was -0.045 for QD and -0.065
for BID (difference= -0.020 loglo c/mL/day (p=o.o65)). In
additional analyses, the differences in slope of VL decline from
Days 3-14, Days i-1io, and Days 3-10 were -0.00oo9 (p=o.355), -
0.036 (p=o.oo6), -0.024 (p=o.o42), respectively, in favor of the
BID arm. The mean change from BL (95% CI) in VL at Day 14 was
-0.585 (-0.728, -0.442) and -0.849 (-1.067, -0.630) loglo c/mL in
the QD and BID arms, respectively (p=o.o56). A faster initial
decline in VL was observed in the BID arm compared to the QD
arm; both arms achieved a mean reduction in VL of >o.5 loglo
c/mL. Both dosing regimens were well tolerated and safety
profiles were comparable. No serious adverse events (SAE) or
Grade 3/4 AEs were reported.
Conclusion: This study provides evidence that ZDV administered
QD has antiviral activity as monotherapy, but further larger
studies of ZDV 6oomg QD as part of combination regimens are
required to assess this dosing regimen in the clinical setting.
Corresponding author: Hill-Zabala, Christina, 5 Moore Drive,
Mailstop 17.1349C.1C, Research Triangle Park, NC 27713,
United States, Tel: [phone], Fax: [phone],
Email: [email protected]

40 Program Supplement