Abstract Book Vol. 2 [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

XIV International AIDS Conference

Abstracts WePeC6262-WePeC6265 145

21 months apart. A standardized interview and physical examination for clinical
signs was performed at each survey. The incidence of lipoatrophy was analyzed
in stratified and multivariate analyses for its relationship to immunologic, virologic,
clinical and drug tratment information for each patient.
Results: Of 337 patients with no lipoatrophy at the first survey, 44 (13.1%) developed moderate or severe lipoatrophy between the two surveys. In multivariate
analyses significant risk factors for incident lipoatrophy were: white race (OR 5.2;
95% CI, 1.9-17.1; p=0.003); CD4+ T-lymphocyte cell count at Survey 2 less than
100 cells/mm3 (OR 4.2; 95% CI, 1.3-13.1; p=0.013); and body mass index less
than 24 kg/m2 (OR 2.4; 95% CI, 1.1-5.4; p=0.024). There was no association with
the duration of use, initiation, continuation, or discontinuation of any antiretroviral
medication with the develoment of lipoatrophy. Analyses that controlled for severity of HIV illness showed no significant effect of any antiretroviral agent or class
of agents on the incidence of lipoatrophy.
Conclusion: Factors associated with severity of HIV infection, especially CD4+
T-lymphocyte cell count, appeared to have the strongest association with the development of lipoatrophy.
Presenting author: kenneth lichtenstein, 4545 east 9th avenue, suite 120, denver, colorado, 80220, United States, Tel.: [phone], Fax: [phone],
E-mail: [email protected]
WePeC6262 Cardiovascular risk in infected HIV patients
J. Garcia Moreno, J. Lomas, F. Rodriguez, E. Pujol, D. Merino. Hospital Juan
Ramon Jimenez, HOSPITAL JUAN RAMON JIMENEZ, RONDA NORTE SN,
21005, HUELVA, Spain
Background: To detect and measure the cardiovascular risk (CVR) in our HIV
patients, account taken that the metabolic changes induced by the highly active
antiretroviral therapy (HAART) may induce an increase of this risk.
Method: 133 patients where applied the Framinghan protocol to estimate the
cardiovascular risk: age, gender, smoking, total cholesterol, HDL, systolic arterial
pressure. Level of risk at 10 years of cardiovascular disease onset <5% low, middle between 5-9%, moderated 10-19%, high 20-40%, and very high more than
40%. We correlate risk with HAART, duration and kind of treatment, and stage of
the HIV disease.
Results: 112 male gender, 21 female. Average age 39.05 yr (SD 7.18). Global
CVR 5.62%. 60.2% low risk, 21% middle, 10.5% moderate, 7.5% high, 0.8% very
high. We grouped CVR as low<5% and non low as 5% or higher. Male CVR
6.34% (middle), Female 1.81% (low), p=0.002. Between 26-34 years CVR 2.07%,
35-44 is 5.83%, 45-54 years 11.58%, and in older than 55, 9.2%. Patients under
HAART (116) with CVR 5,79%, without HAART(17) 4.47% (p=0.14). Patients under Protease inhibitors treatment (77), CVR of 5.78%, without PI (39) risk 5.82%.
The PI do not increase significatively the risk(p=0.16). AIDS patients risk 5.93%,
non AIDS 4.96%, non significant difference (p=0.36).
The average levels of cholesterol is higher in patients with HAART (p=0.02): patients under PI have lower levels of total cholesterol and HDL although without
statistical significance. The systolic AP is higher in patients under treatment although without significance. (p=0.24).
Conclusions: The CVR of our patients is low excepting the older than 45 years,
in which would be appropriate applying primary prevention programs.
Presenting author: JUANA GARCIA MORENO, HOSPITAL JUAN RAMON
JIMENEZ, RONDA NORTE SN, 21005, HUELVA, Spain, Tel.: [phone],
Fax: [phone], E-mail: [email protected]
I WePeC6263 No evidence of mitochondrial DNA depletion in
peripheral white blood cells after three to 12
months of HAART
E.L. Hammond, D.A. Nolan, E. McKinnon, S.A. Mallal. Centre for Clinical
Immunology and Biomedical Statistics, Royal Perth Hospital, Perth, WA,
Australia
Background: Anti-retroviral therapy is associated with decreased mitochondrial
DNA (mtDNA) in adipocytes. We sought to determine whether measurement of
mtDNA in differing populations of peripheral blood also reveals depletion in patients treated with anti-retrovirals.
Methods: Twelve patients were selected who commenced triple therapy including
stavudine as part of the INITIO study. Longitudinal samples of frozen buffy coats
were selected from each patient prior to therapy, after 3 to 4 months on stavudine
and then at 6-12 months of stavudine or 3 months after switching to zidovudine.
Extraction of different cell populations was performed using dyna-beads that targeted specific cluster determinants CD19, CD8, CD4, CD14, CD15 and CD45.
DNA was extracted from each cell population using minicolumns and measurement of mitochondrial DNA per cell was determined using real -time quantitative
polymerase chain reaction.
Results: No significant change was detected in measures of mitochondrial
DNA/cell in buffy coats taken after 3 to 4 months on stavudine compared with

drug naive levels. Eight patients demonstrated a decrease in DNA copy number
on therapy and of these 6 demonstrated a moderate, but not significant, increase
in mitochondrial DNA after several months on the same (or switched) therapy.
Interestingly, two patients showed marked increases in mtDNA in macrophages
after 3 months on stavudine. Measurements of mitochondrial DNA did not reveal any significant correlation between time on therapy and mitochondrial DNA
depletion in the total buffy coat or any of the cell populations examined.

Conclusion: The measurement of mitochondrial DNA copies/cell in peripheral
blood cell populations did not detect significant mitochondrial DNA depletion after
3 to 12 months of HAART. Possible confounding factors may include differences
in cell population kinetics, activation state and mitochondrial organelle mass.
Presenting author: Emma Hammond, Centre of Clinical Imunology and Biomedical Statistics, L2 North block, Royal Perth Hospital, Wellington Street, Perth,
Western Australia, Australia, Tel.: [phone], Fax: [phone], E-mail:
emma.hammond @ health.wa.gov.au
WePeC6264 Predictors of hypercholesterolemia in the HAART
era in the Aquitaine Cohort, France, 1996-2000
F Colombani1, E. Balestre1, P. Merci62, F Bonnet2, R. Thiebaut1, F Dabis'.
1University-INSERM U330, ISPED-INSERM U330, Universit6 Victor Segalen
Bordeaux 2, Bordeaux, France; 2CHU, Bordeaux, France
Objective: To evaluate predictors of hypercholesterolemia (HCT) in HAART
treated HIV-1 infected patients in a prospective cohort.
Design and patients: Subjects of the Aquitaine Cohort aged over 18, treated
by HAART (&iexcl;Y3 drugs) with a protease inhibitor (PI) or a non nucleoside
inhibitor (NNRTI), enrolled before December 31st, 2000 with at least one measure of cholesterolemia of less than 5.2 mmol/L and triglyceridemia less than 2.2
mmol/L at the initiation of HAART.
Method: Univariate and multivariate Cox model were used to explain the occurrence of HCT >5.2 mmol/L after the initiation of the HAART regimen using the
following prognostic variables: age, gender, body weight, AIDS stage, CD4 cell
count, plasma HIV viral load, transmission group, triglyceridemia > median (1.36
mmol/L) and group of treatment (PI versus NNRTI).
Results: 280/489 patients experienced severe HCT (279 cases per 1000 personyears of follow-up, 95% confidence interval [CI]= 246-312). In univariate analysis,
age, gender, AIDS stage, CD4 cell count, viral load were not associated with
HCT occurrence (p> 0.05). PI or NNRTI treatment was not significantly associated with HCT occurrence (relative hazard [RH]= 0.89; CI= 0.62-1.27; p= 0.514).
Body weight > median (64 Kg) (RH= 1.43; CI= 1.12-1.84), triglyceridemia > 1.36
mmol/L (RH= 1.69; CI= 1.33-2.15) and homosexual HIV transmission group (RH=
1.48; CI= 1.17-1.88) increased the risk of subsequent HCT In the final multivariate model, only triglycerides > 1.36 mmol/L (RH= 1.55; CI= 1.16-2.07) and body
weight >64 kg (RH= 1.36; CI= 1.01-1.83) remained the significant predictors of
HCT Homosexual HIV transmission category was of bordeline significance (RH=
1.37; CI= 0.99-1.90; p= 0.059).
Conclusion: HCT occurrence under HAART is associated with higher body
weight and triglyceridemia. We did not find any differential effect of PI vs. NNRTI
on the risk of HCT.
Presenting author: francoise colombani, isped-inserm U330, universite victor
segalen Bordeaux 2, 146, rue leo saignat, 33076 bordeaux cedex, France, Tel.:
[phone], Fax: [phone], E-mail: [email protected]
WePeC6265I Pharmacovigilance and HIV infection:
retrospective analisys of 6 years of antiretroviral
adverse drug reactions reported to a National
Pharmacovigilance System
F. Braganca, E. Teofilo, L. Pinheiro, R. Rosa, R. Carmona, A. Fariavaz,
V.A.J. Maria. National Institute of Pharmacy and Medicine (Infarmed), National
Pharmacovigilance Center, Lisboa, Portugal
Background: Adverse drug reactions (ADR) are increasingly recognised in HIV
infected patients. Focus on HIV infection as a chronic disease, requiring therapy
for increasingly longer periods of time and the need for early availability of new
drugs, emphasises the importance of post-marketing safety surveillance of antiretroviral drugs (ARVD). The objective of our study is to characterise the pattern
and profile evolution of ARVD ADR reported to a National Pharmacovigilance
System (NPS).
Methods: A retrospective analysis of the Portuguese NPS database of ADR was
conducted. The cases of ARVD ADR reported from January 1996 to December
2001 were selected, analysing demographic data, drugs involved, type and seriousness of ADR.
Results: From 1996 to 2001 there was a significant increase in the number of
reports (4 in 1996 to 32 in 2001) with a total of 82 individual cases, 74% of which
were serious (45% with hospitalization). Male predominance was found across all
age groups (74% of the total), with an age distribution paralleling the data from
national HIV infection epidemiology with a peek in the 4th decade (33%). Nucleoside Reverse Transcriptase Inhibitors were responsible for the majority of the
ADR reported. The system more frequently involved was the mucocutaneous. Although ARVD represent 7% of the drugs approved in the European Union through
a centralised procedure, in our series ARVD ADR represent 28% of all ADR associated with centrally approved drugs.

Conclusions: In an era where the availability of ARVD is slowly transforming HIV
infection into a controllable disease, ADR emerge as a new concern, raising the
need for a continuous and structured analysis of clinical patterns and morbidity
associated with these drugs. Our data suggest that there is growing awareness of
this problem, shown by the sustained increase in the number of ADR reported. In
this context global pharmacovigilance systems have a major role in the definition
and monitoring of ARVD safety profiles.