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

Mo.B.196 - Mo.B.293

Monday, July 8, 1996

Lessons Learned: Inservice educational programme on AIDS information was successful in
allaying the irrational fear and enhancing compassionate care to AIDS patients. AIDS information is included in the syllabus as part of curriculum for the nursing students.
Mrs. Jebamani Augustine Nursing Superintendent, C.M.C. Hospital Ida Scudider Road,Vellore
- 632004, India. Phone No: 22 102 -Ext. 2062
Mo.B.196
OUTCOMES OF AN UNDERGRADUATE HIV/AIDS NURSING ELECTIVE:
INSIGHTFUL LEARNING TO PROMOTE QUALITY CARE
Wyness, M.Anne*, Goldstone I*,TrusslerT.* *University of British Columbia, ** British
Columbia Centre for Excellence in HIV/AIDS, *** National Health Promotion Project, AIDS
Vancouver,Vancouver, B.C., Canada.
Issue: Research has shown that nursing students' knowledge about HIV/AIDS is frequently
inadequate and that fostering the values, attitudes, skills and professional confidence
required to provide quality nursing care is the major challenge for educators.
Project: An undergraduate HIV/AIDS elective was developed in collaboration with leaders
of AIDS service and advocacy organizations and health professionals directly involved in
HIV/AIDS prevention and care Outcomes were evaluated to: I) elucidate ways the course
experience influenced students' knowledge, values and attitudes and 2) delineate effective
teaching-learning strategies.The first 3 times the course was taught, focus group interviews
were conducted during the last class. Six months later, each student participated in a short
telephone interview.The interview tapes were transcribed and content analyzed.
Results: Students reported that the course forced them to confront their attitudes and
values and often described individual experiences as "life-changing".The course structure
promoted didactic and experiential learning and was influenced by individual student's
experiences. Dealing with stigma and fear were key experiences as were meetings with
persons with HIV/AIDS. Many students felt impelled to educate friends, family members
and health professionals.
Lessons Learned: Students are challenged to examine values and attitudes when they are
taught by individuals directly involved in HIV/AIDS prevention and care and those living with
HIV/AIDS. Small group teaching, in a climate that promotes reflection and sharing of
thoughts and feelings, is essential.Teachers must examine the responsibilities inherent in
providing transformational experiences for students.
M. Anne Wyness, Associate Professor:T201-221 I Wesbrook Mall,Vancouver, BC,V6T 2B5,
Canada.Tel: [phone]/Fax. [phone]/e mail. [email protected]
Mo.B.290
EFFECT OF NUCLEOSIDE ANALOGUE RT INHIBITORS ON PLASMA HIV RNA AND
CD4 COUNT AS AN INDICATOR OF CLINICAL EFFECT
Phillips AN, Eron J*, Bartlett *, Hill AM*t for the North American Lamivudine HIV
Working Group. Royal Free Hospital School of Medicine, London, UK, *University of North
Carolina at Chapel Hill, USA, *Duke University Medical Center, Durham, North Carolina,
USA,** Glaxo Wellcome Research, UK.
Objective: To assess the extent to which the effect of combination therapy with z dovudine +
lamivudine (3 TC) on plasma HIV RNA and the CD4 count is translated into a clinical effect.
Methods: For 620 patients randomised in the North American NUCA300I (n=366;
zdv/3TC vs zdv vs 3TC in zdv naive patients) and NUCA3002 (n=254; zdv/3TC vs
zdv/ddC in zdv experienced patients) trials, plasma HIV RNA levels were measured using
the Roche method, and CD4 counts were assessed at a central laboratory (both measures
available median 7 times per patient). Patients were in CDC stages A (n=439), B (n= 135)
or C (n-=46) at baseline.Two Cox model analyses of the risk of clinical disease progression
were performed: (i) baseline CDC A/B > AIDS (CDC C) and (ii) baseline CDC A ->
CDC B or AIDS.When HIV RNA level and CD4 count were included in the model the
current (latest) value was fitted as a time dependent covariate.
Results: At baseline, CD4 counts and HIV RNA levels were similar in the two treatment
groups (zdv/3TC treatment arms vs the rest) in each trial (median baseline values for all
subjects: HIV RNA 42,420 copies/rnl; CD4 count 277 /mm3). During the trial there was a
sustained statistically significant lower HIV RNA level and higher CD4 count in the zdv/3TC
group (difference in median area under curve per month: HIV RNA 0.38 lOg 10 copies/ml;
CD4 count 0.18 log2 /mm3). For patients initially CDC A/B the adjusted relative hazard of
AIDS for a 2 fold difference in CD4 count was 3.1 (95% Cl 1.4 - 6.7) and for a log 10 difference in HIV RNA 3.2 (I 2 - 8.6); this did not differ significantly between treatment groups.
Given these associations with progression and treatment differences in CD4 count and HIV
RNA, a relative hazard for risk of AIDS (for those not on zdv/3TC vs the rest) of 1.9 [ie
exp((0.18 x In3. I) + (0.38 x 1n3.2))] would be expected, while the observed value was 6.3
(I.4 - 29.4). After adjustment for the HIV RNA level/CD4 count this was reduced to 2.7
(0.5 - 13.2). Sinilar results were obtained when the combined endpoint CDC B/C disease
was used.
Conclusions: In this analysis of two trials, the effects of zdv/3TC in reducing plasma HIV RNA
and raising peripheral blood CD4 counts appear to have been translated into clinical benefit.
Andrew Phillips, HIV Research Unit, Dept. Primary Care 8. Papulat orn Scences, Royal Free
Hospital School of Medicine, Rowland I-ill Street, London NW3 2PF, UK.
Tel: UK 17 1794-0500 x 4238 Fax: UK 171 794-1224, errai: [email protected]
Mo.B.291I
A RANDOMIZED, COMPARATIVE TRIAL OF ZDV VERSUS ZDV PLUS DDI VERSUS
ZDV PLUS DDC IN PERSONS WITH CD4 CELL COUNTS OF <200/MM3.
Saravolatz, Louis D. Collins G, Hodges D, VVinslow D. Pettinetli C.
Terry Berr Con munity Pr ograms for Clinscal Research on AIDS 007 Protocol Team, NIAID,
Bethesda, Maryland, USA
Objective: To compare the effcacy of zidovudine (ZDV) alone, ZDV given with didanosine
(ZDV + ddl), and ZDV given with zalcitabine (ZDV + ddC) in delaying disease progression
or death in patients with AIDS.
Methods: I 1 3 patients (254 antirretdovral arve, 859 antiretroviral experienced) were randomrzed openly to ZDV (600 rg/d) and ddl or ZDV and ddC and the randomized in a
double blind fashion, in a 2: I ratio, either to active ddl (400 mg/d) or its placebo or to
active ddC (2.25 mg/d) or its placebo.Treatment groups were compared for clinical disease
progression and survival, toxicities and CD4 response.

Results: Bschie c. r:,rinstics were well balanced amog the treatment arms: 92% were
male, 45' nn, 2 had used intravenous drugs, the median CD4 count was 92
cell/mm3 an,- the rr,.,Iduration of prior ZDV use was 7 months. Median follow-up was
34 months wit a a.: status unknown. Disease progression or death occurred in 222
of 366 patents a -' D - DV + ddl, 232 of 372 patients assigned ZDV + ddC, and 242 of
375 patients assi rred ZF-!only (p=0.19), with neither combination arm differing significantly from the monother apr arm (RR=0.84, p=.07 for ZDV + ddl and RR-0.93, p-=.76 for
ZDV + ddC).trhe e was no difference in m ortality between the three arms. For ZDV-naive
patients, combinatiorn r. 'rpy reduced the rates of disease progression or death (p<.01),
with ZDV + ddl providing the most reduction (RR--0.54, p<.0I), findings consistent with
other studies.The ZDV - ddl arm had a significantly higher rate of GI-related toxic ties, and
the ZDV + ddC arm had a significantly higher rate of neuropathy. Mean changes in CD4
count at 2 months were significantly higher in the combination arms w th similar declines
after two months in each treatment arm.
Conclusions: CPCPA 007 shows a marginal benefit and higher toxicity for ZDV + ddl and
ZDV + ddC compared to ZDV monotherapy ZDV naie patients received a significant benefit from combination therapy (ZDV + ddl; ZDV + ddC) compared to ZDV monotherapy.
Louis D. Saravolatz, M.D., Infectious Diseases Division, CF- 104 Henry Ford Hosp tal,
2799 W Grand Blvd., Detroit, MI 48202 Tel: [phone] Fax: [phone]
Mo.B.292
HIV VIRAL LOAD CHANGES IN DELTA PATIENTS
Brun-Vezinet F. The Delta Virology Group, France, UK, Netherlands.
Objective: To study correlation between viral load changes, immunological evolution and
clinical outcome in a subset of Delta I AZT-naive patients.
Methods: A total of 230 patients were recruited in 22 selected centers in France, UK and
Netherlands for virological studies including viral load quantitation. Quantitative cellular and
plasma cultures were performed by a consensus methocology at -2. 0, 42, 24, 48. 64 and
96 weeks. Plasma RNA measurements were assayed by the Monitor Roche Molecular
Systems assay on specimens collected twice at baseline, monthly up to week (WVV) I 6, every
other month until W64, then every four months.
Results: Of the 230 patients, 85 had been randomised to Zidovudine (AZT) monotherapy
73 to AZT + Didanosine (ddl) and 72 to AZT + Zalcitabine (ddC). At baseline, the virology subset patients had a mean and a median CD4 cell count of 210 [IQR: 123-280]; 52 %
were symptomatic, 31% had ARC and 17% AIDS. Quantitatree cellular viremia were positive
n 9 I % of the patients at baseline. Up to W48, the area under curve of the log titer was significantly different (p=0O000I) for AZT from combination therapyThere was no significant
difference between AZT+ddl and AZT+ddC groups. Plasma cultures were positive at baseline in 62% of the p rtients.There was no significant difference in the percentage of negatvation on sequential specimens between the 3 'reatment;roups.
The preliminary analyses of RNA results showed that the greatest mean reduction
observed atW4 was 0.47 log in AZT 1.53 log in AZT+ddl and 1.22 log in AZT+ddC
groups. At W48, in AZT monotherapy group the mean NA viral load was back to the
baseline value while in combination arms the decrease was sustained: -0.74 log in AZT+ddl
and -0.91 login AZT+ddC. At W80 a decrease of at least -0.6 log persisted in both combination therapy groups.
Conclusions: These first results showed a significantly greater and more sustained reduction
in HIV viral load in both combination therapy groups th,.n in AZT ronotherapy group.The
correlation with the response in CD4 ce ount and the clinical outcome are under study
F. Brun-Vezinet, Laboratoire de Virologe. Hpital Bichat, 46 rue Henn Huchard, 75018 Paris,
FranceTel: 33 1 40 25 88 96 Fax: 33 I 46 27 02 08
Mo.B.293
SUPPRESSION OF PLASMA HIV RNA BY REVERSE TRANSCRIPTASE INHIBITORS
PREVENTS AIDS AND DEATH IN ACTG 175; COMBINATION AND MONOTHERAPY
WITH ZDV, DDI AND DDC
Katzenstein David A, Hammer 5, Hughes M, Gundacker H, Jackson B. Fiscus S. Lathey J.
Rasheed S, Reichman R, ElbeikT Japour A, D'Aquila R, Scott W, Griffiths B,Winters M,
MeriganT, Hirsch M. ACTGVirology StudyTeam, Stanford University Medical Center:
Stanford, CA.
Objective:To Determine the importance of CD4 cells, quantitative HIV plasma viremia and
syncytia inducing (SI) virus on 50% CD4 cell decline, AIDS, and death in a study of reverse
transcriptase inhibitor (RTI) therapy; specifically ZDV, ZDV/ddl, ZDV/ddC, and ddl in subjects with 200-500 CD4 cells
Methods: Plasma HIV RNA, by PCR (Roche) was perfornmed on frozen samples obtained
twice at baseline, and at 8, 20, 56, 80, and 104 weeks in 1 67 subjects randomized to the
ACTG 175 study at I Isites. Cell culture isolates from 330 subjects were tested for syncytia
induction (SI) in an MT 2 co cultivation assay Analyses are proportional hazard models for
risks of a 50% CD4 cell decline, AIDS or death.
Results: 78/39 I (20%) of subjects had a 50% fall in CD cells, AIDS or death, 48 (I 2%)
AIDS/death and 28 (7%) died. Hazard ratios (HR) examined in multivariate proportional
hazard models show:

50% CD4 fall/AIDS6 Deaths AIDS/De aths
CD4 / 100 cells/ mm3 1.24 (p0.16) 1.20 (p"-0.33)
HIVRNA/Iog 10 3.98 (p<0.001) 5.65 (p<0. 001)
NSI/SI Phenotype SI vs NSI 3. 16 (p<0.00 1) 2.8I (p-=0.004)

Deaths
1.09 (p-0.74)
5.28 (p<0.00 1)
2.63 (p<0. 04 1I)

Changes from baseline to week 8 in HIV RNA and CD cells were examined in proportional hazard models. For changes in HIV RNA/lOgl0 copies/ml the HR for 50%CD4
fall/AIDS/Deaths was 0.27, (p<0.00 I), for AID/death 0.38 (p-0.00 I), and for death 0.40
(p=0.0I 3). Changes in CD4 cells/100/mm3 were associated with a HR 0.62 (p-=0.002) for
50%CD4 fall/AIDS/ Deaths, 0.72 (p=0.09) AIDS/Death, and 0.71 (p=0. 15) death.
Conclusion: Plasma HIV RNA level at study entry and SI phenotype are significant, independent factors contributing to the risk of AIDS and death in subjects treated with RTIs.
Decreased plasma RNA following therapy (week 8) was associated with significantly lower
risk of CD4 cell decline, AIDS and death.
DA Katzenstein, Infectious Diseases, S- 156, Stanford University Medical Center, Stanford, CA
94305-5107 Telephone: [phone] Fax: [phone] E-mail: ml.dakoforsythe.stanford.edu

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