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

12th World AIDS Conference

Abstracts 42254-42330 839

phine, and placebo. The Risk Assessment Battery (RAB) was administered at
study entry and at the conclusion of the efficacy study. This instrument provides
estimates of Drug and Sex Risk Scores, and Total Risk Scores for HIV risk
behaviors. Study participants were less severely opiate dependent than most
methadone patients and thus were less likely to be HIV seropositive at baseline.
Standardized psychosocial behavioral treatment including HIV education was part
of the study design.
Results: 313 participants were evaluated by the Risk Assessment Battery at
study entry and at week 4. In a preliminary analysis of the total sample, there
are significant reductions (p -.05) in HIV Risk behaviors for all study arms.
Restricting the analysis to those with moderate to significant risk behaviors at
baseline (N = 97)), there is a trend toward reductions in Drug Risk and Total
Risk scores (p -.1) in the buprenorphine group compared to placebo. For those
participants followed at least 6 months there appears to be a maintenance of HIV
risk reduction on an individual basis.
Conclusions: In a sample of moderate opiate dependent patients seen in an
office based setting, there is a significant reduction in reported HIV risk behaviors
during a 4 week controlled trial of buprenorphine-naloxone, including a trend in
treatment effect for those with a moderate or greater baseline risk score. An open
safety trial continues, and 6 month data show maintenance of HIV risk reduction,
thus supporting the clinical intent to reduce HIV risk through office based opiate
treatment.
42326 Double blind placebo controlled trial of oral
dehydroepiandrosterone (DHEA) in advanced
HIV-infected patients
Christophe Piketty', D. Jayle', B. Debuire2, A. Leplege3, Y. Lebouc4,
E.E. Baulieu3, M.D. Kazatchkine5. 'Department of Immunology - Hospital
Broussais 96 Rue Didot 75014 Paris; 2Hospital Paulbrousse Villejuif; 3lnserm
U33 - Hospital Bicetre Le Kremlin Bicetre; 4Hospital Trousseau, Paris; 5lnserm
U430 and Department of Immunology Paris, France
Objective: Plasma levels of DHEA sulfate (DHEA-S) are decreased with the
progression of HIV disease. We report on the efficacy and safety of DHEA in
HIV-infected advanced patients in a trial primarily aimed at assessing scores of
quality of life.
Methods: The trial was randomized, double blind. Thirty two patients were
allocated to either DHEA 50 mg per day for 4 months (n = 14) or a matching
placebo (n = 18). Clinical data, virologic and immunologic surrogate markers of
HIV infection, plasma levels of DHEA-S, and the MOS SF-30 quality of life scale
were recorded every month during follow up.
Results: The mean age of the patients was 40 - 11 years. The mean CD4 cell
count at baseline was 32.5 + 32.4 x 106/L. The mean DHEA-S plasma level at
baseline was 1.9 i 1.7 mg/mL. A statistically significant increase in the levels of
DHEA-S was observed in the treated group (p - 0.01). A significant improvement
of Mental Health of MOS SF-30 was observed in the DHEA treated group (p =
0.016, cronback a = 0.81). No change in CD4 cell count was noted during the
follow up. No side effect related to DHEA occurred during the study.
Conclusion: Administration of DHEA in advanced HIV-infected patients resulted in a benefit effect as assessed by mental function scores of MOS SF-30
quality of life scale.
42327 Alternative therapy use in patients with HIV: "Snake oil"
or panacea?
Mark Keiserman, J. Tuveson, J. Maimares Schmidt, L. Kim, D.I. Abrams,
J. Koch. U.C. San Francisco, 1001 Potrero Avenue 3D, San Francisco, CA
94110, USA
Background: We studied the use of complementary and alternative medications
(CAM) and prescription medications (PM) in patients infected with the HIV.
Methods: Prospectively in 1997, all new patients referred to the HIV-Gastroenterology-Nutrition clinic were asked to complete a self-administered questionnaire
and undergo comprehensive nutritional and medical evaluation. CAM was defined
as daily use of one or more of the following: mega-dose vitamin/mineral, herbs,
"metabolics" (e.g. yohimbe, dihydroepiandrostenedione). Adverse risk behaviors
(ARB) were tobacco, alcohol and illicit drug use. Mean values, t-test/Chi-square
p values are shown.
Results: Complete information was available for 86% (112 of 130) patients,
109 men and 3 women. 53 patients (47%) reported CAM use and 59 did not
(non-users). There were no differences between the groups in age (p = 0.3),
years HIV positive, weight, viral load (p = 0.9), use of testosterone (p = 0.3) or
anti-diarrhea medication (p = 0.4).
HIV+ Weight BCM CD4 count Albumi Any # PM AntiYrs (Ibs) % cells/mm3 ng/dl ARB retroviral
CAM (N = 53) 7.3 162 64.5 353 4.1 28% 5.2 62%
Non-users (N = 59) 7.3 156 59.6 229 3.8 54% 5.6 73%
p value 0.9 0.2 0.06 0.01 0.003 0.009 0.48 0.3

Conclusion: CAM use is reported by nearly half of patients with HIV infection. Patients take CAM in addition to rather than as substitutes for prescription
medications. CAM use was not associated with any identifiable negative outcome
measure. CAM users have fewer adverse risk behaviors than nonusers suggesting more health awareness. Significantly higher body cell mass, serum albumin
and CD4 cell count suggest that CAM users are healthier than non-users.

S42328 Effects of aerobic and resistive exercise training on body
composition, immune markers, and viral load in HIV+
adults with CD4+ counts 200-499/mm3
Barbara A. Smith', J. Neidig2, J. Nickel2, D. Frid2, M. Para2, R. Fass2.
1 University of Alabama School of Nursing, Birmingham, Alabama, USA; 2 The
Ohio State University, Columbus, OH, USA
Objective: To determine the safety of a supervised aerobic and resistive exercise
protocol for HIV infected adults and its effects on listed variables.
Methods: Sixty HIV+ men and women were randomized to exercise or control.
Heart rate monitoring and personal trainers assured exercise at appropriate intensity. Time on treadmill, (TOT), aerobic power (VO2), body weight, % body fat
(skinfold), lymphocyte subsets, and viral load (log HIV RNA) were measured.
Results: Groups did not vary significantly at baseline on demographics, weight,
CD4 or viral load. Subjects reported no untoward effects.

n
TOT 14
V02 17
Wt (kg) 16
%Fat 15
CD4% 15
CD4 15
HIV RNA 12

Exercise
Wk 0 Wk 12
8.9~1.5 9.9~1.7
34.715.8 37.3~6.3
84.8~16 83.2~13.4
14.8~7.6 12.1~6.9
21.7- 8.2 20.618.3
337+71 325+103
3.8 0.9 3.9 1.0

change n
1.0~0.9 28
2.5~3.1 29
1.6~4.8 27
-2.7~3.6 28
-1.1 13.0 25
12+82 25
0.2 10.4 24

Control
Wk 0 Wk 12
8.511.3 8.6+ 1.4
31.515.6 32.6+7.3
84.7~12.6 85.1~12.8
19.2~9.2 18.9~8.6
21.9+8.0 22.7 17.6
350 102 3741112
3.9: 0.9 3.61 0.8

change
0.2~0.9
1.0~3.4
0.4~2.5
-0.3~4.1
0.7 2.6
24~80
0.2 i.7

p.006.067.530.014.057.186.053

Conclusions: Significant increases in V02 and TOT and the lack of adverse
events indicate that HIV + adults can be safely conditioned. The decrease in body
fat without a decline in weight suggests that lean muscle mass can be increased.
Exercise had no clinically significant effect on viral load. Increases in CD4 cells
were not seen in this sample in contrast to previous reports.
Supported by NINR # 5 R01NR0394 and NIAID # A1259424
42329 "Kootikuppala compound": A promising drug for HIV
positive persons - A pilot study
Surya Rao Kutikuppala', R. Subhakar Raju2, M. Guru Lakshm 113, S. Pushpa1.
1Child Foundation of India, Visakhapatnam; 2Dept. of Pharmacy Govt of
Andhra, Visakhapatnam; 3CFI AIDS Prevention Division, Visakhapatnam, India
Objective: To study the therapeutic effect of 'Kootikuppala Compound' on HIV
positive people.
Design: Prospective controlled study.
Methods: Patients with confirmed HIV infection through ELISA and Western
Blot were included in the study. We excluded patients who received any other
therapy six months priorer to inclusion in the study group. 'Kootikuppala Compound' made with judicial combination of different ancient herbs which have
proven safety on human usage against a variety of chronic illnesses of unknown
eiology, have been tried on 60 HIV positive patients for a period of 15 months from
August 1996 to October 1997 divided them into two groups of 30 (thirty) each
of Group-A and Group-B, in which Group-A received placebo and the Group-B
'Kootikuppala Compound'.
Results: There is a remarkable improvement in general conditions, weight
gain, control of cough, fever and diarrhoea and oral candidiasis of 21 (70%)
positive individuals while 3 (10%) persons did not follow the treatment regularly
and rest 6 (20%) are asymptomatic where as in the group received placebo there
is deterioration of the general condition of the 24 (80%) persons; while 4 (13%)
did not show any changes and 2 (7%) are drop-outs. There are no side effects
except bloating of the stomach among 5% of the study groups. We could not
perform CD4 counts as these tests are not available in our parts.
Conclusion: This pilot study clearly shows the efficacy of 'Kootikuppala Compound' which needs further study and evaluation on large scale on more number
of subjects at different centres as this drug is available for a low price which is with
in the reach of patients from developing countries. The cost of monthly treatment
with this 'compound' is about 15 US dollars for an AIDS patients. The probable
action of this drug is by inhibiting the replication of the virus and also building up
the immunity.
42330 | Effect of an amino acid mixture containing
3-hydroxy-/3-methylbutryate (HMB) in HIV related wasting
John A. Rathmacher', Robert H. Clark2, G. Feleke2, M. Din2, T. Yasmin2,
F. Khan2, R. Powers', S.L. Nissen', J.C. Fuller, Jrl, N.N. Abumrad3. 'Metabolic
Technologies, Inc., 2625 N. Loop Dr, Ste 2150, Ames, IA; 2Nassau County
Medical Center East Meadow NY; 3North Shore University Hospital, Manhasset,
NY USA
Background: HMB is a metabolite of the amino acid leucine that when fed to exercising humans has been shown to increase muscle mass and function (J. Appl.
Physiol. 81:2095-2104) by decreasing muscle proteolysis. In certain conditions
1-Arginine and 1-Glutamine have also been shown to increase immune function
in humans. It is postulated that the amino acid combination with HMB could result
in a synergistic action of these amino acids on both muscle metabolism as well
as immune function. Previous studies have been completed which established
the safety of this mixture.
Objective: A study has been initiated to examine the effectiveness of an
AA/HMB mixture in altering the lymphocyte and CD4 cell counts and preventing
muscle wasting in patients with established HIV.