Abstracts Vol. 1 [International Conference on AIDS (11th: 1996: Vancouver, Canada)]

Track B: Clinical Science

Mo.B. 1145- Mo.B. 1150

The most common clinical adverse events included fatigue, headache, diir rhea, and nausea,
all of which were common pretreatment and occurred on study with similar frequency in
the control groups. Mild taste alteration and rash were noted mor e frequently among pts
receiving CXN than control therapy Nephrolithiasis was reported in 3/120 (2.5%) of CXN
pts; none of these pts discontinued. Isolated indirect hyperbilirubinemia without other liver
function test abnormalities was frequently observed but did not lmit therapy.
Conclusions: CXN in these trials exerted potent and sustained intiviral actvity CXN was
generally well tolerated.
J. A. Chodakewitz, Merck Research Laboratories, PO. Box 4, BL3-4, West Point, PA
Telephone: [phone], Fax: [phone]
Mo.B.1 145
EFFICACY AND SAFETY OF MDL 28,574A IN HIV-POSITIVE PATIENTS WITH
BASELINE CD4 VALUES OF 301 - 500
Richmond, Gary jv, Zolnouni P**, Stall Jv*, McPherson M, Hamedani P Cross V, Sidarous E,
Stoltz M"****. *Ft. Lauderdale FL, USA; *California Clinical Trials, Beverly Hills CA, USA;
**Clinical Research Center, Sarasoata FL, USA; ****Hoechst Marion Roussel, Kansas City
MO, USA
Objective: MDL28,574A (MDL), a butanoyl denrivative of castanospermine, a naturally
occurring plant alkaloid, is under development for use in the delay of the progression of disease in HIVpositive patients. MDL is an o-glucosidase I inhibitor which acts ii the latter
phases of viral replication by altering glycoprotein processing which results in the reduction
of viral infectivity and syncytial formation.This activity on a host (vs viral) enzyme is thought
to provide long-term activity against the virus. MDL has been shown to be synergistic invitro with zidovudine (ZDV), ddl, ddC, nevaripine, and saquinavr This presentation will discuss the preliminary surrogate efficacy as well as safety results of Phase II rnlticenter studies conducted in the US and Europe.
Methods: Randomized, double blind, MDL in doses of 50, 150, 300, 400rng or matched
placebo, once daily, were taken dunring a 12 week monotherapy treatment period Patients
then entered a combination treatment period wherein, they continued on blinded MDL or
placebo combined with open-label ZDV 200mg tid, for an additional 12 weeks. Inclusion
criteria consisted of adult HIV-positive patients who were asymptomatic or mildly symptomatic, without AIDS defining events. Exclusion criteria consisted of patiens who had > 6
months prior exposure to any single antiretroviral agent. Efficacy endpoints consisted of
HIV-RNA, CD4 and p24. Safety was assessed with serial, clinical laboratory assessments and
documentation of clinical adverse events.
Results/Conclusions: Over 170 patients have been randomized and entered this trial todate. No significant serious adverse events have been attributed to MDLI. Dropout rates are
approximately I 4% and are due primarily to voluntary withdrawal, rnonconmpliance, and GI
adverse effects. Preliminary results from an interim assessment of efficacy and safety will be
displayed using the surrogate efficacy data and safety displayed using adverse event summaries and summaries of clinical laboratory trends.
Gary J. Richmond, MD; 3 15 South East 14th Street, Ft. Lauderdale, FL 3331 6
Tel. #: [phone]; FAX #: [phone]
Mo.B.I 146
DOES LEGISLATION IMPROVE THE SAFETY OF BANKED BLOOD IN SINGAPORE?
THE EXPERIENCE WITH HIV AND HEPATITIS B.
Kan, Elena- + **, Ong, Douglas- + **. *Alexandra Hospital, Singapore," Singapore
General Hospital, ** Action for AIDS Spore
Singapore detected its first case of HIV in 1985. All banked blood has since been serologically screened for HIV. Screening also includes a I to I interview using a donor health
assessment questionnaire modified since I1986 to include risk faIctors for IIV Since 1989,
donors have been further required to sign a statutory declaration. False declarations are
punishable by prosecution and this was widely publicised in the media. In I1992, further
deterrent measures were introduced by passage of a bill in parliament making punitive
measures more severe for those who made a false statutory declaration.This was followed
by conviction and wide press coverage of 2 donors found to have HIV
We conducted a retrospective study of the incidence of HIV in donor blood in the time
periods 1987 88, before a statutory declaration was required; 1989 9 1, before passage of
the parliamentary bill and 1992-94 after the bill was passed. A total of 327,651I donors
were studied. During these three time periods, 7, 7 and I I cases were confirmed by
Western blot respectively (Incidence 0.009%, 0.006% & 0.009%; p>0. I). Because of the high
prevalence of Hepatitis B carriage (6%), Hep Bs Ag is also routinely screened.The incidence
of Hep B in the same periods was 2.2%; 1.5% & 1.2% (p<0.00000 1). Subanalysis further
confirmed a change in donor profile.
We conclude that legislation is effective in ensuring the safety of banked blood against Hep
B.The prevalence of HIV in our local population is too low to show significance. However,
using Hep Bs Ag as a surrogate marker of HIV, we surmise that the effect is likely to be the
same on HIV.
Elena Kan 213 Yishun St 21 #04--171 S'pore 2776, Singapore Tel.: [phone] Fax: (65)
463 - 220 Email: [email protected]
Mo.B.I 147
EVALUATION OF RAPID HIV1/2 DOUBLE SPOT AND STAT PAK TESTS
Surapol Kohreanudom, Chaiyos Kunanusont, Wiput Phoolcharoen. AItS Division,
Department of Communicable Disease Control, Ministry of Public Health,Thailand
Background: More HIV rapid test kits are commercially distributed in Thailand because of
increasing awireness of HIV transmission risk.The major application is to test emergency
donated blood especially in community hospitals where standard safe blood supply system
is not well institutionalised.
Oblective:To evaluated validity of two commercial test kits ailabc inThailand
Methods: Known 100 serum specimens (50 HIV+ (43 strongly 7 weakly). 50 HIV) were
tested for anti HIV using the Rapid HIV 1/2 Double Spot lest (Universal Resource
Enterprise). A total of 5 false negative were reported thus giving 90% sensitivity and 100%
specificity. Positive predictive value was 100% while negative predictive vaue was 91%.
Overall testing validity was 95%.The test failed to identify S from / weakly positive sera.
Following the same logistics, but different panel sera, known 608 serum spec wens (197

HIV+ (I 83 strongly, 14 weakly), 4 I1 HIV-) were tested for anti HIV using the HIV 1/2 STAT
PAK (Chembio Diagnostic Systems). A total of 14 false negatives with I false positive were
reported thus giving 93% sensitive and 99.8% specific with positive and negative predictive
values of 99.5% and 96.7% respectively Overall testing validity was 97.5%.The test failed to
identify all It weakly positive sera.
Conclusion: Due to the failure to identify weakly positive specimens as HIV positive and the
great risk of transfusing donated blood fr-om early seroconverters (during the "window peni
od") in Thailand, these rapid test kits should not be used solely to screen emergency blood
for donation.
Surapol Kohreanudom AIDS Division, Dept of Communicable Disease Control, Ministry of
Public Health, Nonthaburi I I000,Thailand. Fax [66]-(2) 5903210
Mo.B.I 148
TRAINING FOR SAFE BLOOD PROGRAMMES IN SUB-SAHARAN AFRICA
Goddard, Judith M., Kataaha P K, Ssenyonga P Nakasero Blood Bank, Kampala. MOH
Uganda. Uganda Blood Transfusion Service is sponsored by The Commission of the
European Cornmmunities.
Issue: Blood transfusion in sub-saharan Africa carries a high risk of transmission of HIV,
Hepatitis B and C, Malaria and other infections. Prevention is by deferral of high -risk donors,
testing of blood for infection markers and restricting blood transfusion to life threatening
situations. Imnplementation requires competent trained staff
Project: During 1991 - 1993 UBTS provided five day courses to teams of at least one doc
tonr one technician and one nurse from every hospital in Uganda. Instruction gave detailed
guidelines on the selection of blood donors and recipients and on testing donated blood
for anti-HIV.The cost ($180 per hospital team) was by a grant from WHO (through national ACP). In 1994 and 1995 one of us visited 59 hospitals and evaluated the results of this
training.
Results:
Yes Response

Has the technician responsible for blood transfusion attended a course? 2 -Is the technician who attended the course in this blood bank? I_
Did any trained person pass on information to peers in this hospital? 22
Are blood donors deferred on national guide lines? 5C
Are transfusion recipients audited for indicalton and response?
All hospitals combrrbined.What was the rate of
HIV positive blood donations in 1991 and 1994? 16.0%
What was the rate of HBsAg positive blood donations in 199 I and 1994? 6.9%
What was the rate of false positive and negative HIV tests* 4%
*All positive samples and 20% of negative samples done at hospitals by rapid test are
repeated by ELISA at NBB.

3
2
0
8
7.9%
7.7%
<1%

Lessons Learned: The training courses did not significantly improve blood transfusior safety.
Training needs to be repeated frequently and passed on to other hospital staff the individuals ictually responsible must be trained; hospitals must audit donor and recipient selection;
communication between hospitals and UBTS must be improved.
Judith M. Goddard, Nakasero Blood Bank, PO. Box 1772, Kampala, Uganda
Telephone: 256-4 I -257155 Fax 256-41 I 257484 email: [email protected]
Mo.B. I 149
PREVALENCE OF HIV IN DIFFERENT CATEGORIES OF BLOOD DONORS
ATTENDING A FIXED SITE IN KAMPALA
Opollo, Marc S, Aciro, B. Goddard, J.M. Nakasero Blood Bank, Kampala
Objective: To analyze the prevalence of HIV in different categories of blood donors
Method: Everyone coming to donate blood at the fixed site at Nakasero Blood Bank were
counseled prior to donating blood, this included interviews and physical observations to try
and exclude blood from people in the window period or who are HIV seropositve.They
were categorized into: replacement donors (RD), new voluntary donors (ND), and regular
voluntary donors (RVD). Post donatinon counseling was only available to voluntary donors.
Results:

sO
>
ON
0
u
c
cO
o
5(
0
C)
0
Q)
u
L)
0
U
c
0
o
8
x
80

YEAR
1991
1992
1993
1994
1995

DONORS HIV+ve RD
3210 447(1 3.9) 1890
281 I 309(11.0) 1432
2184 151(6.9) 619
1698 105(6.2) 417
1722 92( 5.3) 342

HIV+ve ND
325(17.2) 61 1
232(16.2) 465
69(I 1.1) 474
53(12.7) 300
46(13.4) 298

HIV +ve
84(1 3.7)
48(10.3)
44( 9.3)
22(7.3)
23( 7.7)

RVD
709
914
1091
981
1082

HIV+ve
38(5.4)
29(3 2)
38(3 5)
30(3.1)
23(2.1)

Conclusions:The prevalence of HIV in all categories of blood donors reduced by 8.6%.
However the prevalence of HIV in replacement blood donors increased in 1994 and 1995.
The prevalence of HIV was reduced in all the volunteer blood donors. More research is
requirecd to determine the reasons why replacement donors receiving the same pre-donation counseling consistently have a higher prevalence of HIV at the fixed site, which is situated about one mile away f-rom the hospital.
Marc Sam Opollo, Nakasero Blood Bank, Po Box 1772, Kampala, Uganda.
Fax: 256 - 4 - 257484
Mo.B. I 50
EVALUATION OF ENCOURAGEMENT STRATEGIES FOR REGULAR VOLUNTARY
DONORS TO ENSURE AN ADEQUATE SUPPLY OF SAFE BLOOD.
Stein, Millicent F, Nyamgenge M, Kataaha P K. UBTS, Kampala,. MOH Uganda. Project
funded by Canadian Development Fund, Barclay's Bank, Voluntary Service Overseas, ODA
and EEC/EDF
Objectives: I.To obtain a supply of safe blood. 2.To increase awareness of the dangers of
IV infection in blood donated. 3,To educate the public on how best to obtain safe blood,
that is through the practice of self-deferment after unsafe sexual activity.
Methods: I. Re organization of mobile teams to specific areas in order that the public
becomes familiar with the donor team. Installation of a donor base for all donor sessions.