Bridging the Gap: Conference Record [Abstract book, International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

814 Abstracts 42205-42209

12th World AIDS Conference

Conclusion: After 12 months of treatment with AZT/3TC/protease in two randomised trials, the estimated percent undetectable ranged from 46% to 78%
depending on the statistical methods used. Results expressed as "percent undetectable" and "loglo reduction" are highly dependent on analytical methods used.
Analyses including only the patients remaining on treatment can overestimate
virological efficacy and are prone to bias. Standardisation is essential for reliable
comparison of treatment effects in different clinical trials.
42205 | Color method validation for HIV+ CD4 analysis
transported to a central clinical trials laboratory
H. Mike Neisler1, W.R. Williams1, A. Shiba2. 1Covance, 8211 Scicordrive,
Indianapolis, IN 46214; 2Becton Dickinson Immunocytometry, San Jose, CA,
USA
Objective: Validate 4 color MultiTESTT~ reagents and MultiSET" software for
CD4 Direct Absolute Count use across long term clinical trials within a central
laboratory environment.
Methods: 60 samples from both HIV- and HIV+ subjects across a range of CD4
percent and absolute counts were compared using MultiSET~" 4 color methods
and traditional 3 color applications. All sample were prepared in TruCount'" tubes.
20 additional samples from high risk HIV- and HIV+ subjects were evaluated for
stability across 72 h at stabilized ambient temperature.
Results: Correlation between the 3 and 4 color data were excellent. The intraand inter-assay precision and reproducibility for MultiSET'" were excellent. In 100
reanalysis of the same LIST mode file by MultiSETM exactly the same results
were always produced, which was not possible for a manual 3 color reanalysis.
Samples stability at 24 h, 48 h & 72 h in stabilized ambient temperature for
both CD4% (Correlation 0.995, 0.996, 0.990) and CD4 Absolute (0.997, 0.989, &
0.979) were excellent.

3 vs 4 Color
Mean
Slope
Intercept
Precision
Mean
SD
C.V.

CD4%
34.04
0.980
0.064

CD4 Abs
764
1.019
-6.44

CD4% CD4 Abs
11 140
0.8 15.0
7.5 10.7

Methods: We compared the number of patients enrolled in A.N.R.S. clinical
trials and the rate of errors in antiretroviral prescriptions before and after implementation of an expert system. This expert system automatically suggests
patients' enrollment into specific clinical trials or cohort studies on the basis of patient's current and prior treatment, CDC stage, CD4 cell-count and HIV viral load.
Moreover it displays a warning signal before printing antiretroviral prescriptions
(after comparison with guidelines).
Results: ADDIS has been operating since 1994 with a total of 1283 patients and
5860 records. Two 5-month periods were compared. The number of enrollments
into A.N.R.S clinical trials increased (from 14 to 59). Moreover the prescriptions
error rate was 6% before the expert system implementation and 0% after.
Conclusions: Our computerized HIV medical record (ADDIS") already improves quality of care through its user-friendly interface and numerous capabilities. It now allows physicians to be more aware of possibilities of enrollment into
clinical trials or cohort studies and improves safety for antiretroviral prescriptions.
42208 Lessons learned in an HIV/AIDS clinical trial to improve
patient enrollment and compliance
Maria de Lourdes Garcia Garcia1, Manuel Palacios Martinez2, L. Ferreyra
Reyes2, J. Martinez Badillo3, V. Campos Hernandez3, M. Ramos Madrigal3,
J.L. Valdespino Gomez2. 1Ave Universidad 655 Cuernavaca Morelos C.P
62508; 2 nstituto Nacional de Salud Publica Cuernavaca MO; 3Fundacion
Mexicana de Lucha Contra El Sida Mexico DF, Mexico
Objective: To analyze several strategies to improve patient enrollment and compliance in clinical trials.
Methods: A multicentric prospective, clinical trial for chemoprophylaxis of tuberculosis was conducted in Mexico City from Dec, 1993 to October 1997 on
non pregnant adult, HIV-1 positive, Karnofsky scale above 60%, PPD positive
subjects. Different strategies to improve enrollment and follow up were analyzed.
Results: Strategies which resulted in improved enrollment were: 1) Recruiters
from the same social group 2) Respect to confidentiality 3) Courtesy 4) Physicians without sexual or moral prejudice towards participants 5) Providing diverse
clinical sites with a variety of schedules. To improve follow up: 1) Scheduled appointments 2) Physician-patient relationship 3) Unchanged clinical sites 4) Home
or phone visits by teams which include men and women trained for confidential
and discreet outreach who identify themselves as friends or companions (not as
health workers).5) Adequate referral system for diagnosis and management of
AIDS associated diseases Factors having negative impact in patient compliance:
1) Not checking addresses and telephones at enrollment 2) Lack of continuity of
psychological counsel 3) Changing the location of clinical sites 4) Changing physicians without an adjustment period (The new physician should be introduced and
recommended by the departing one preventing patient's feeling of abandonment).
Conclusions. Patients enrollment and compliance in clinical trials can be improved through strategies that focus both on human aspects and on quality of
care. Lack of prejudice, adequate patient-physician relationship, referral systems,
outreach activities, and flexibility of services are essential issues to be considered. Partially funded from National Institutes of Health (USA)/Panamerican
Health Organization
42209 Issues of recruitment and retention in an intervention for
HIV+ gay Puerto Rican men
Milagros N. Mendez1, J. Calderon2, B. Ortiz-Torres2, E. Iglesias2, I. Vega2,
F. Perez2. 1 PO. Box 23345, San Juan 00931-3345; 2Univ of Puerto Rico, San
Juan, Puerto Rico
Issues: Recruitment and retention strategies within the context of an intervention
that seeks to determine the effectiveness of a group empowerment model among
HIV+ gay Puerto Rican men.
Project: A randomized trial with two conditions (control and treatment) with
follow-up at three time points. Participants in treatment condition attend a twelvesession intervention including areas such as: disclosure, homophobia, social
support, safer sex, coping with losses, physician-patient relationship, alternative
treatments, adherence to treatment, nutrition and social support.
Results: An evaluation of the different recruitment strategies at different phases
of the intervention point to specific obstacles and recommendations. The obstacles
encountered in the project seem related to the methodology and research design
of the intervention, the impact and current stage of the condition of seropositive
on the patients, the "in/out of closet" status of the participants within a latin culture
context, and the homophobic attitudes of health providers, the media and society
at large, among others. On the more positive side, the motivation to participate
and attend to interventions like this stem from a heightened sense of commitment
to helping others, a need for social support and for recommendation of an agency
and/or case worker with whom they have established a close relationship. These
results are of paramount importance when one of the main objectives of the
investigation is the dissemination of the model of intervention to the community
at-large.
Lessons Learned: Recruitment and retention strategies must take into account

the specific characteristics of the context in which the intervention takes place.
There is a need to develop novel and unique culture-sensitive strategies.

Conclusion: 4 Color MultiSET' provide a consistent platform with excellent
precision and sample stability for central laboratory monitoring of long term cellular
responses during clinical trials.
42206 Design and validation of a standardized four-color panel
for monitoring early T-lymphocyte responses in clinical
trials
H. Mike Neisler1, M. Lederman2, D.L. Kelleher3. tCovance Central Laboratory
Services, Covanve, 8211 Scicor Drive, Indianapolis, IN 46214; 2Case Werstern
Research Univ, Cleveland, OH; 3Glaxowellcome, Research Triangle, NC, USA
Objective: Develop a precise 4 color flow cytometry design to monitor T-Lymphocyte response across long term clinical trials within a central laboratory
environment.
Methods: FITC/PE/PerCP/APC labeled antibody combinations were evaluated and prepared to monitor CD25, CD28, CD38/HLA-DR, CD45RACD45RO,
CD45RACD62L, & CD95 expression on both CD4+ & CD8+ lymphocytes. Sample
stability was evaluated across 72 h at stabilized ambient temperature.
Results: 12 custom conjugate combinations were prepared each as single lots
under GMP to provide: a single isotype control, consistent fluorescent responses,
antibody-fluorochrome consistency, intra-panel validation, analytical simplicity,
and sample transportability. Standardized instrument set-up and templates allow
cross-instrument and cross-laboratory acquisition &/or analysis without loss of
precision (Typical c.v. <10.0). Automated sample mixing and acquisition provided
walk-away acquisition with subsequent technologist analysis. Minimal gate or
cursor adjustments were required across the 4 standardized acquisition/analysis
templates producing analysis time of <3 min per patient. Typical inter-tube precision of CD4 was 623/cmm ~ 40.9, c.v. 6.6; and 33% ~ 0.9, c.v. 2.8. Samples
transported at stabilized ambient temperature were stable for up to 48 h with
typical correlation coefficient >0.95.
Conclusion: Standardized antibody formulation, templates, and instrument
set-up provide a consistent platform for central laboratory monitoring of long term
cellular responses during HIV treatment trials.
42207 Improving patients' enrollment into clinical trials: The
experience of a computerized medical record (ADDIS ))
Pascal F. Pugliesel, S. Wehrlen2, C. Pradier1, O. Keita-Persel, J.F. Chambon3,
A. Mousnier2, P. Dellamonical. Infectious Diseases Dpt L'Archet BP79 06202
Nice Cedex 03; 2Pharmacy Hopital L'Archet, Nice; 3Glaxo-Wellcome, Paris,
France
Objectives: to assess the efficacy of an expert system implemented in a computerized medical record in order to facilitate patients' enrollment into clinical trials
and to avoid inadequate antiretroviral prescriptions.