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

Mo.B.175 - Mo.B.183

Monday, July 8, 1996

Methods: Seven studies used a 3-period crossover design: IDV given alone, in combination
with the other drug of interest, and the other drug given alone. Plasma sampling after 7 to
1 0 days of dosing: N= 1I0 to 14 per study
Results: Plasma drug exposure (AUC) data are presented as geometric mean ratios (GMR)
with 90% confidence intervals (Cl) for IDV in combination/to IDV alone and for-other drug
in combination/to the other drug alone. A 90% Cl between 0.5 and 2.0 signifies no clinically significant drug interaction occurred
Drug IDV TMP SMX IDV AZT IDV d4T
Dose 400 mg 160 mg 800 mg 1.0 gm 200 mg 800 mg 40 mg
q6h ql2h ql2h q8h q8h q8h.. l2h
GMR 0.98 1.18 1.05 1.05 I.17 095 1.21
(90% (0.81, (I.05, (1.01. (0.86, (1.07, (0.8, (I.09,
CI I.18) 1.33) 1.09).28) 1.29) 1. 12) 1.33)
Drug IDV INH IDV CLR IDV RFB IDV FCZ
Dose 800 mg 300 rmg 800 mg 500 mg 800 mg 300 mg 1.0 gm 400 mg
q8h qam q8h q l2h q8h qam q8h qam
GMR.99 1.12 I.19 1.47 0.66 2.73 0.76 1.00
(90% (0.87. (I.03, (I 00, (I.30, (0.56, (I.99, (0.59, (0.96,
CI 1.13) 1.22) 1.42) 1.65) 0.77) 3.77) 0.98). 1.05)
TMP/SMX=trirnethop irr/sulfamethoxazole; AZT=zidovudine; d4T-stavudine; I NH=isoniazid; CLR-clanthromycin: RFTrifabutin; FCZ-fluconazole
Conclusions: No clinically signifcant interacton occurred with TMP/SMX, AZT NH, d4T
nor FCZ.
Coadministration with IDV increases the plasma concentrations of both CLR and RFB, presumably competition for P-4503A active site.This interaction is considered clinically significant only for RFB. RFB also decreases the plasma concentration of IDV.Thus, a dose adjustment to one half the standard dose is recommended for RFB when coadministered with
IDV, if no alternatives.
Dr Jacqueline B. McCrea, Clinical Pharmacology Merck Research Laboratories, P.O. Box 4, BI12-7,
West Point PA, 19486 USA Tel: [phone] Fax: [phone]
Mo.B. 175
A TRIPLE COMBINATION OF RITONAVIR+AZT+DDC AS A FIRST LINE TREATMENT
OF PATIENTS WITH AIDS: UPDATE.
D Mathez, P Bagnarelli, P De Truchis, I Gorin, C Katlama, G Pialoux, C. Ruggeri, AG Saimot, R
Tubiana, JP Chauvin. M Clementi, J Leibowitch*. University and Pasteur Institute Hospitals,
Paris France;Abbott Laboratories, France;Ancona University Italy
Objective: To combine one potent HIV- I protease inhibitor with 2 synergistic nucleoside
analogues in treatment-nave patients with advanced HIV infections.
Patients and methods: 29 virus-culture positive HIV- I infected adults with less than 250
CD4/pl were offered an ethical review board-approved open label combination of
Ritonavir+AZT+DDC (I 200 mg, 600 mrg, 2.25 mg/day respectively). Log infectious blood
cells /107 PBMC, limit of detection = 0.7(a), and log HIV RNA copies/ml plasmas,
Amplicor Roche Monitor 36 cycles, hlimit of detection I(b), were sequentially determined in
real time.

well-being and weight gain No toxicologic abnormalities were observed in standard hematological and chremrical parameters. No other adverse events were reported.
Conclusion: 5PV-- 3O appears to be a safe and efficacious adjunct therapy in the treatment
of HIV d isese, v'rn for i,ose individuals with more advanced immunosuppression.
Arlette Pharov '91 outwest Fwy Suite 200, Houston,Texas, 77027 Tel: [phone]
Fax: [phone]
Mo.B.181
NATIONWIDE LONGITUDINAL OUTCOMES STUDY OF HIV/AIDS
ALTERNATIVE THERAPIES
Standish, Leanna I., Calabrese C., Reeves C. Bastyr University AIDS Research Center
Seattle, WA, USA
Objective: The Bastyr University AIDS Research Center was established in October 1994
by the NIH's Office of Alternative Medicine.The mission of the Center is 1) to describe
forms and patterns of use of alternative medical (AM) therapies for the treatment of HIV+
patients, either prescribed by practitioners or self-administered; and 2) to screen and evaluate therapies for the treatment of HIV/AIDS from five AM program areas (nutrition, traditional and ethnomedicine, energetic therapies, pharmaco ogical and biological therapies, and
bioelectromagnetic medicine).
Methods: The Center has established a network of collaborating AM clinics, begun recruitment of 1500 HIV+ men and women who are using AM to participate in the study, and has
created a centralized database which allows us to compare clinical, laboratory and quality of
life outcomes among a variety of alternative therapies. Outcomes information is being collected on people using 170+ alternative therapies. Primary outcome measures include progression rate, survival, change in CD4, swt, and quality of life over 2 years. We are collecting
evidence on whether health outcomes differ in people who use both conventional medicine
(anti-retrovirals and antibiotic prophylaxis) and AM vs. those who use only conventional
medicine or only AM.The rate of AIDS-related opporturistic infections and neoplasms in
people using specific AM will be compared to the incidence in those who use only conventional medical treatment.
Results: Recruitment began in October 1995.We have enrolled 60 clinical recruitment sites
into our practitioner network.These sites are located throughout the U.S.Treatments
offered by the 60 clinics fall within at least one of the five AM program areas. Each clinic is
treating an average of 100 HIV+ patients.To date, 105 HIV+ individuals have enrolled (87%
men, 13% women).
Conclusion: Both alternative medical practitioners and HIV+ men and women using alternative therapies are collaborating with the Center in orcer to evaluate health outcomes
associated with a diversity of alternative therapies. An epidemiological, outcomes method
for assessing alternative medicine in HIV/AIDS is appropriate and feasible.
LJ Standish, Bastyr University AIDS Research Center t154 54th St. Seattle,WA, 98105, USA
Tel: [phone] FAX [phone] email: js@bastycedu
Mo.B. 182
A STANDARDIZED CLINICAL ASSESSMENT TOOL ON THE USE OF ALTERNATIVE
THERAPIES BY HIV POSITIVE INDIVIDUALS.
Sabo. Carolyn E.*, Paterson M.A.*, Carwein V.L.**. *University of Nevada, Las Vegas;
**University of Washington,Tacoma
Issue:There is currently rio standardized cisnical tool to assess the use of alternative therapies in HIV positive individuals.
Project: A tool which can be used to assess the use of alternative therapies in HIV positive
individuals is developed based on a survey of I 27 HIV positive individuals who used alternative therapies. Therapies were grouped into 6 groups: diet therapies, ingested substances,
alternative spiritual therapies, relaxation therapies, touch therapies, and prayer:
Results:The results of the survey showed that while on y 16% of the sample used alternative therapies before HIV infection, 100% of the sample used such therapies after infection.
Additionally there were strong correlations between groups of therapies suggesting that
users of at least one alternative therapy are highly likely to use other alternative therapies.
Lessons Learned: Given the universal use of alternative therapies in the study population,
assessment of the use of such therapies in HIV positive individuals is an important aspect of
the clinical history. An effective assessment 'ool reust consider use of multiple alternative
therapies since there are strong assoiatiorns between types of alternative therapies used.
Carolyn E. Sabo, R.N.. Ed.D., University of Nevada, Las Vegas, College of Health Sciences
4505 Maryland Parkway Box 4530 1, Las Vegas. NV 89154-3019 Telephone: [phone]
Fax: 702-895- I 356 ensail: csabo(dccmail.nevada.edu
Mo.B. 183
USE OF ALTERNATIVE TREATMENTS FOR HIV: PATTERNS AND CORRELATES
Collins, Rebecca L.*, Kanouse, DE*, Senterfitt, JW*, McCutchan, A]#,Wenger, NSs'*,
Fleishman, JA, Marshall, GN, Kelly, MD, Grant, I#, Bozzette, SA#*, for HCSUS
Consortium. *RAND, Santa Monica, CA, #UCSD, San Diego, CA, **UCLA, Los Angeles,
CA, USA, ##Agency for- Health Care Policy and Research, Rorkville, MD. USA
Objective: To detern thseso t ve treatents Si to
disclose this to medical providers or substitute those tiratments for more conventional
therapies. and to identify correlates of these beavors behavior
Methods: One hundred forty HIV+ per-sons being followed at the UCSD Neurobehavioral
Research Cerster comspleted a mailed questionnaire as part of instrumeirt development for
the national DIV Cost and Services Utilization Study (HCSUS).They indicated whetlier* they
had used each of 10 alternative therapies in the past 6 months, whether- the alternatives
were used instead of conventional treatment, and wheteer the therapy was discussed with
a medical provider Single items measured attitudes toward treatment and dying; scales
assessed optimism and coping.
Results: Seventy-six percent of the sample (nt 106) had recently used some type of alternative treatment, 44% (n-6tI) without telling their meed cal provider Fourteen percent used
these therapies in lieu of traditional treatments; 8% (n-IlI) manipulative or spiritual therapies. I12% (n-1I6) ingested substances.Those wee substituted alternatives for conventional
treatments were more optimistic (p<.05), expected to live longer (pC.001I). were less likely
to have an advance directive (p<.05), and were less interested in making end-of-life preparations (pC.00 I ).Therapy substitution was negatively related to coping by preparing for the 1

Results:
Cells(a)
<detectable
RNA(b)
<detectable
CD4

monrths
Mean
+ISD
n
Mean
~ISD
n
Mean
~ISD
n

0
3.28
0.63
0
4.64
0.64
0
173
76
29

1.61
0.55
I
2.72
0.75
3
281
91
28

2
1.10
0.40
3
2.35
0.85
5
280
87
26

3
1.03
0.39
3
2.41
I.09
6
291
108
24

4
1.07
0.49
5
2.37
0.94
5
288
72
21

5
0.92
0.28
7
2.28
I.14
8
314
116
21

6
0.96
0.33
6
2.51
1.00
5
303
116
21

7
0.91
0.32
6
2.31
1.00
4
298
94
17

8
0.90
0.33
6
2.53
1.16
4
295
97
15

9
0.84
0.27
10
2.64
1.17
4
313
109
17

Conclusion: Open label trials assessing she antiviral effectiveness of drugs in real time allow
for a rapid identification of potent antiretroviral combinations at low costs and without the
need of control groups.
Dominique MA1HEZ, F-opital Raynrond Poincare 92380-- Garches FRANCE
Mo.B. 180
EVALUATION OF THE SAFETY AND EFFICACY OF SPV-30 (BOXWOOD EXTRACT)
IN PATIENTS WITH HIV DISEASE
Pharo, Arlette, Salvato, P. Thompson, C., Stokes, D., Mastman, B., R. Keister: Twelve Oaks
Hospital, F louston,Texas, USA.
Objective: lo determine if SPV-30, an all natural boxwood evergreen extract, manufactured
by Arkoph,itrma in France is safe and efficacious in HIV disease.
Methods: HIVI viral load measured by RNA PCR and dDNA, CD4 counts and CD8,
counts were evaluated in 173 HIV patients. Baseline viral load ranged from virtually no HIV
detectable to mone than two million copies. Baseline CD4 ranged 0 to 860. Baseline CD8
ranged from 42 to 3269.Thease measured of immune function were assessed at study initiation, 2 months, 4 months, and again at 6 months. Hematological and chemical parameters
were assessed every two months.
Results: Viral Load: 63% participants experienced decreases in viral load after six months.
38% experienced decreases of greater than 50% or 0.3 log. For participants with viral load
greater than 40,000 at baseline, 66% experienced decreases in viral load. 35% experienced
decreases of greater than 50% or 0.3 log. 4 1% exoerienced increases in CD4s with a median change of -5 and -8.5% after six months. For participants with less than 200 CD4s at
baseline, 44% experienced increases with a median change of -2 or -14.3%. 52% experienced increases in CD8 counts with a median change of +22 or -2. 1% after six months. For
participants with less than 500 CD8s at baseline, 69% showed increases with a median
change of +76 and +31.5%. No sgnificant toxicities were noted. Mild transient episodes of
diarrhea and abdominal cramping were occasionally noted as side effects. In most participants, side effects included noted inprovenent in diarrhea and skin conditions, increase in
energy, increased appetite, improvement in concentration and memory, overall sense of

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