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

samples were obtained over 24 hr on days i, 8, 9 and 15. PK
parameters were calculated using noncompartmental methods.
Statistical tests included generation of 90% confidence
intervals (CI) for the ratio of geometric means [GMR (90% CI)]
for tenofovir and ddl AUC and Cmax given together vs. alone.
Results: ddl EC had no effect on the PK of tenofovir (GMR 90%
Cl within 80 to 125%). ddl systemic exposures were increased
by 48% when dosed in a fasted state, two hours before TDF
with a light meal [AUCo-,,V 1.48 (1.31, 1.67); Cmax 1.48 (1.25,
1.76)]. ddl exposures were similarly elevated when ddl EC was
given simultaneously with TDF and a light meal [AUCo-,,V 1.6o
(1.44, 1.79); Cmax 1.64 (1.41, 1.89)].
Conclusions: Administration of ddl EC 2 hours prior to or
simultaneous with TDF and a light meal resulted in elevated ddl
exposures relative to ddl EC alone in the fasted state. Further
evaluations, including considerations of dosage adjustment for
ddl EC, are warranted.
Corresponding author: Cheng, Andrew, 333 Lakeside Drive,
Foster City, California, 94404-1147, United States,
Tel: [phone], Fax: [phone],
Email: [email protected]
[LBPEB90271
Effects of different first-line HAART regimens on the content
and function of lymphocyte mitochondria of HIV-infected
patients without lipodystrophy
Ldpez, S, Mird, O, Martinez, E, Rodrguez, B, Milinkovic, A, Predrol,
E, Casademont, J, Nunes, V, Gatell, JM, Cardellach, F (Spain)
Background: Mitochondrial (mt) toxicity is supposed to be the
deleterious effect of nucleoside reverse transcriptase
inhibitors. We comprehensively assessed mt content and
function in easy-to-obtain samples such as peripheral
lymphocytes.
Methods: Five groups of HIV-infected patients without clinically
evident body fat changes were studied: one antiretroviral-naive
(control group) and the others receiving highly active
antiretroviral therapy (HAART) consisting on AZT+3TC or
d4T+ddl plus either nelfinavir (NFV) or nevirapine (NVP) for at
least 6 months. The relative abundance of mtDNA respect to
nuclear DNA was determined by real time PCR. Mt content was
estimated by citrate synthase activity. Enzyme activity of
complexes III and IV of the electron transport chain (ETC) was
spectrophotometrically determined. Oxygen consumption was
polarographically measured in intact lymphocytes and in the
presence of complexes I and III substrates.
Results: We included 25 untreated and 42 treated HIVpatients. Groups were comparable in age and gender. Only
those groups receiving d4T+ddl exhibited significant mtDNA
depletion. Mt content was significantly lower in all treated
groups, showing NFV-containing HAART group the greatest
decrease. Antiretroviral schedules containing either NFV or
d4T+ddl were associated with a significant decrease of enzyme
activity of complex IV, being the greatest decline found when
NFV and d4T+ddl were combined in the same schedule.
Despite previously mentioned differences, all oxidative
activities remained normal.
Conclusions: Peripheral lymphocytes can be used to detect
different degrees of mitochondrial toxicity of HAART regimens.
Despite the abnormalities found, functional capacity of
lymphocyte mitochondria remained normal. These results
suggest caution on interpreting abnormal mitochondrial
function test because it does not necessarily translate into an

abnormal functional capacity. (FlIPSE 3102/oo, La Marat6 TV3
01/1710, SGR 00279).
Corresponding author: L6pez Moreno, Sonia, Fundaci6 Clinic,
c/ Villarroel, 170, 8036, Barcelona, Spain,
Tel: [phone]oo00 ext.2907, Fax: [phone],
Email: [email protected]
Track C
[LBPEC9028
Telling the truth in microbicide trials: using audio computerassisted self-interview (ACASI) to assess the accuracy
of self-reported behavioral data in a Phase II clinical trial
Norris Turner, Abigail, De Kock, Alana2, Sebola,
Mohlatlego2, Meehan, Amy3, Blanchard, Kelly2, Hoosen,
Anwar, Coetzee, Nicol2, Ellertson, Charlotte'
('Mexico; 2South Africa; 3United States)
Background: Assessing the reliability of self-reports of sensitive
behavior, particularly in HIV-prevention microbicide trials, is
critically important. If participants report their use of study drugs or
devices inaccurately, study conclusions about safety and
effectiveness could be wrong.
Methods: We used audio computer-assisted self-interviewing
(ACASI) to ask about the accuracy of face-to-face interviews
conducted during a Phase II, doubl-blinded, randomized clinical
trial of a vaginal microbicide. We explored whether
embarrassment, fear of criticism, desire to be polite, or other
motivations led women to under- or over-report sensitive sexual
behavior. The ACASI interviews (n=132) took place in August 2001
at two South African sites participating in the Phase II trial.
Results: More than half the ACASI participants (53%) reported that
they lied for one or more reasons during the Phase II trial. More
women lied to be polite (34%) than because of fear of criticism
(24%) or embarrassment (18%). Among sexually active women
(n=95), 5% reported that they lied about how often they had
vaginal sex, 24% lied about how often they used the study gel
alone (without condoms), and 17% lied about how often they used
the study gel together with condoms. In general, women who lied
had actually had vaginal sex more often, used the study gel
together with condoms less often, and used the study gel alone
more often than they reported to the Phase II interviewers. Only
8% of participants preferred being interviewed by a person
(instead of the computer) and 97% found the computer interview
easy.
Conclusions: The results may allow the Phase II investigators to
better understand their findings about this microbicide's apparent
safety, acceptability and preliminary effectiveness. In addition, the
data also suggest that ACASI is a feasible research method for use
in this population, and is perhaps preferable to face-to-face
interviewing for subsequent microbicide trials.
Corresponding author: Norris Turner, Abigail, Escondida #110,
Colonia Villa Coyoacan, Mexico, DF, 40o0, Mexico,
Tel: [phone], Fax: [phone],
Email: [email protected]

XIV International AIDS Conference BARCELONA - JULY 7-12

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