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

Monday, July 8, 1996

Mo.B.294 - Mo.B.303

Mo.B.294
A RANDOMIZED, DOUBLE-BLINDED COMPARATIVE TRIAL OF THE EFFECTS OF
ZIDOVUDINE, DIDANOSINE AND NEVIRAPINE COMBINATIONS IN ANTIVIRAL
NAIVE,AIDS-FREE, HIV-INFECTED PATIENTS WITH CD4 COUNTS 200-600/MM3.
Myers, Maureen W, Julios G. Montanec The Incas Study Group. Italy, Netherlands, Canada,
Australia And U.S.A.
Objective: To compare the safety, tolerability, immunological and vroleric l.tvity of 2 and
3 drug combination therapy regimens including zidovudine (ZDV), didnpi. -e (ddl) and
nevirapine (NVP).
Methods: 152 HIV- I infected patients who were AIDS-free and antirv o.ir itherapy naive
and had CD4 counts 200-600/rmm3 were enrolled in this one year., drrrle blinded randomized comparative study. Study drugs are: ZDV 600 mg/d, ddl 400 mrg/dc (If weight >60 kgs);
and NVP 200 OD for 14 days followed by 200 mg BID thereafteifreatnet arms include
ZDV/ddl/NVP placebo; ZDV/ddl placebo/NVP and ZDV/ddl/NVP Intended blinded followup will be completed April I1996.
Preliminary Results: All sbjects have completed 10 months follow up. 91 of patients are
s- males, 93% are white, rned<n baseline CD4
Ag M~. vh" 1 was 340/mm3. Blind agcregate plasma viral load.results for a subset 01 o 9 patients are shown in
''' the figure. Mean plasma viral load (Amplicor@3Roche) at baseline wais I 1rI c10 and it
decreased >2 log 10 within one month of initiatingd study drugs. 3%e of iall study patients expe2 rienced a severe (Grade 3) rash associated with
35 7. 3,,, 8 the study drugs. Unblinding of the full database
1 2 7 o s 6 will take place in April 1996
Conclusion: Our data demonsrates a very
substantial decrease in plasma viral load when 2 and 3 drug combinations of AZT/ddl/NVP
are used among antiretroviral naive HIV I infected patients with CD4 counts 200 to
600/mm3. Furthermore, AZT/ddl/NVP combinations are generally well tolerated in this
patient population. Supported by Boehringer Ingelheim Pharmaceutic als In.
Dr: Maureen W. Myers Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road,
Box 368, Ridgefield, CT 06877, USA Tel: [phone]; Fax: (203) /98-5433; email: N/A
Mo.B.295
DELAVIRDINE (DLV) COMBINED WITH ZIDOVUDINE (ZDV) OR DIDANOSINE
(DDI) PRODUCES SUSTAINED REDUCTION IN VIRAL BURDEN AND INCREASES
IN CD4 COUNT IN EARLY AND ADVANCED HIV-I INFECTION.
Freimuth WW Chuang-Stein CJ, Greenwald CA, Wathen LK, Edge P,rd,.ry BA, Cox SR,
Daenzer CL, Wang Y Carberry Peter A.
Delavirdine team, Pharmacia & Upjohn Inc., Kalamazoo, Michigan, U.S.A.
Objective: Delavirdine a potent non-nucleoside reverse transcriptase irfnhibitor: effectively
inhibits both RNA- and DNA-directed polymerase functions of HIV I reverse transcriptase
and has been shown to be synergistic with ZDV (in ZDV sensitive and resistant strains) and
ddl in vitro.We are studying the surrogate marker response and clirnic outcome of these
two combination therapies in HIV- I infected subjects.
Methods: HIV- I infected subjects with CD4 count of 200 500 cells (average 320-330) have
been randomized into double-blind therapy with ZDV, ZDV + DLV 200 rng TID, ZDV +
DLV 300 mgTID or ZDV + DLV 400 mgTID.Those with CD4 count 0-300 (average 135)
are randomized into double-blind therapy with ddl or ddl + DLV 400 rmgTID.
Results: Data on 800 ZDV-treated patients show that 60% were ZDV/ naive with 19%
female, 31% non-caucasian and 10% I.V. drug user. Interim surrogate niarker analysis shows
that ZDV + DLV (300 or 400 m TID) increased CD count to 20 -30 cells above baseline
for more than I year and 35-70 cells higher than ZDV alone at 40-60 weeks of therapy At
week 4 of therapy DLV produced about a I log drop in HIV- I RNA, twice that seen with
ZDV monotherapy. ZDV + DIV 300 and 400 mg TID maintained a 0.5 log reduction in
plasma RNA viral load for > I year. Data on 870 of the ddl-treated patients show that 13%
are female, 32% non caucasian, I I% I.V. drug user and all patients were 7DV experienced,
25% for _ 4 months. With DLV + ddl, CD4 counts increased 5-20 cells ibove ddl
monotherapy during the irst 40 weeks, and remained above or near baseline for at least I
year:With DLV + ddl, plasma RNA viral load dropped 0.9 log at week of therapy 2 fold
greater than ddl ilone. [LV + ddl produced a 0.5 log sustained reduction or t least 60
weeks. Subjects on DLV + ddl with serum DLV trough levels > 7 5 piM had sustained CD4
cell increase of 1 5-25 above baseline and HIV-I RNA reduction of > 0.5 log l sting 60
weeks. In both populations, DNA PCR (PBMC) and serum ICDp24 responses correlated
with CD4 and RNA PCR results. DLV dose and serum trough concent' ations correlated
with all surrogate mtriker responses.
Conclusions: Both DLV + ZDV and DLV + ddl therapies showed an excellent safety profile
and sustained antiviral effect.
Peter A. Cafrberry, Phamacia & Upjohn. Inc., 7000 Portage Road, Ka,iazoo, Ml 3.900 -0199
Telephone: [phone]
Mo.B.300
TRADITIONAL MEDICINE IS AVALID LOCAL ALTERNATIVE FOR THE
TREATMENT OF CHRONIC DIARRHEA AND HERPES ZOSTER IN AIDS
PATIENTS IN KAMPALA, UGANDA.
Homsy )l), Kabatesi D*, Kwamya L*, lusaba C*, Kasolo S*, Okello M-, Ssentamu L*, Mwebe
DC, Nshakir N*, Mubiri F*, King R*P. Katabira. * TASO THETA Protect. Kampala,
Uganda (MSF Switzerland, Uganda.
Objective: to evaluate the effectiveness of traditional herbal medicire Irt the treatment of
chronic diarrhea (CD) and Herpes Zoster (HZ) in HIV-infected patients in Kmrpala, Uganda.
Methods: Trials were conducted in 2 phases. In phase I, test patients. were seierted, enrolled
and followed-up at 3 healers' clinics by she healer: a nurse and a doctor: In phease II, test
patients were selected, enrolled and followed-up by the same team at Mulago Hospital,
Kampala. In both phases, controls were recruited from and followed at the TASO AIDS
Clinic of Mulago Hospital. Healers coded their herbal preparations and prescribed their

own dosage and regimen. Controls received the best medical treatment available at the
hospital, including acyclovir for HZ in phase I. Follow-up consisted of standard clinical and
lab exams.
Results: A total of 243 test (200 CD, 43 HZ) and 1 13 control (60 CD, 53 HZ) patients
were enrolled in phase I, while 222 test (88 CD, 134 HZ) and 8 I (39 CD, 42 HZ) control
patients were enrolled in phase II.Total loss to follow-up was 11 I% in phase I and 20% in
phase II. HZ lesions healed at the same rate whether under herbal or medical treatment in
both phases, but significantly fewer healer patients still complained of post-herpetic neuralgia
at the end of follow-up, (I 1% test vs. 44% controls in phase I and I 6% vs. 40% in phase II;
p<0.005). CD responded (no recurrence for at least 2 weeks) significantly more frequently
to herbal treatments than to conventional medicine (69% test vs. 33% controls in phase I;
78% test vs. 25% controls in phase II; p<0.005). In addition, the average time it took for the
diarrhea to stop was also shorter for healer patients in both phases although this difference
was not statistically significant. Finally, CD4 counts were found to decline equally among all
groups of patients, independent of the clinical result.
Conclusion: This study - the first of its kind in East Africa - shows that traditional herbal treatments can be readily evaluated through simple and systematic clinical trials. As the herbal
medicines studied were found to have equal or superior effect than corresponding drugs
available for the treatment of chronic diarrhea and Herpes Zoster in AIDS patients, this result
justifies availing such altemrnatives to patients through conventional AIDS clinics in Uganda.
J Homsy doTHETA, Box 21175, Kampala, Uganda.Tel/FAX: [phone]'619 or 2671113 or
268'498 Email: [email protected]
Mo.B.301
ALTERNATIVE THERAPY USE IN HIV POSITIVE WOMEN
Meneilly Glenda P*, Carr R**, Brown L*. *BC Women and Family HIV Centre, **
Vancouver Hospital and Health Sciences Centre,VancouverB.C. Canada
Objective: To characterize the use of alternative therapies in a group of HIV positive women.
Methods: Forty-two percent (26/62) of female patients attending an ambulatory HIV clinic
were identified as using alternative therapies. Using a structured telephone interview, the
use of alternative therapies in this population was characterized.
Results: Sixteen patients consented to a telephone interview. Demographics: 98% caucasian; mean age 35years(range 21 to 47);years since diagnosis 69% I-4years, 25% 5-10
years;mean CD4 count 4 I13 (range 50-1020);education-62% had post-secondary education.
Fifty-five different alternative therapies were reported in current use (mean 8.5 per patient,
range 2-20).Treatments were categorized as Herbal remedies (38%),Vitamins and minerals
(29%), Relaxation techniques and massage (9%),Folk remedies(2%), Acupuncture(2%),and
Other, such as acidophilus,DNCB,nacetylcysteine (20%). Seventeen different therapies were
reported as discontinued(mean 1.9 per patient,range I-7). Reasons for discontinuing therapy included: no benefit(31I%),too expensive( 19%),side effects( 12.5%),detrimental to HIV
(25%).The most common source of information on therapies was friends (50%), with only
19% of patients getting information from health care workers. Almost 50% said the information they received on these treatments was inadequate. Seventy-five percent of respondents spent over $100 per month on alternative treatments.The average yearly income for
the group was $10.000 to 20,000 per year.ln comparison to previous studies in homosexual
men with similar demographics women with HIV are more likely to use a wide variety of
herbal remedies and less likely to use acupuncture.
Conclusions: Many HIV positive women use a wide variety of alternative therapies.The
economic burden of paying for these treatments is significant, and patients lack sources of
reliable information regarding their use. HIV positive women appear to have a different pattern of alternative therapy use compared to men.
G.P Meneilly OakTree Clinic, B4 West, 4500 Oak St.,Vancouver,BC,V5H 3N I Canada
Telephone:[phone] FAX [phone] email:[email protected]
Mo.B.302
A MODEL OF COLLABORATIVE NATUROPATHIC AND ALLOPATHIC MEDICINE IN
PRIMARY HIV HEALTH CARE
Luby, Kenneth P., Rubin G.,Toronto, ON, Canada.
Issue: The delivery of health care to patients with HIV is continually evolving, driven predominantly by our own patients as they pursue alternatives to allopathic medicine.This has
necessitated openmindedness on the part of physicians and commitment to cooperation
on the part of complementary therapists to ensure comprehensive health care for patients
with HIV
Project: WVe are members of a group medical practice which consists of three primary
care physicians and one naturopath, created two years ago to meet the diverse needs of
our mutual patients.The establishing premise of the practice was that naturopathic medicine would provide preventative health care and allopathic medicine would provide acute
care intervention.
Results:The practice has grown considerably in the past two years, and has seen patients
with lowered incidence of drug-induced side effects and gastrointestinal diseases. Patients
express increased physical and mental energy providing higher quality of life.
Lessons Learned: Patients have expressed feelings that their needs are being listened to in
this multidisciplinary approach to their long term health management. Both naturopathic
and allopathic medical approaches have complementary modalitites to offer in both short
and long term HIV care. Licensed health care professionals from different health care paradigms can work collaboratively to better meet the needs of the complex health issues
affecting people living with HIV
Kenneth P Luby 235 Danforth Ave. Suite 301,Toronto ON M4K I N2, Canada.
Tel.: [phone]
Mo.B.303
META-SURVEY OF PLANT AND HERB MATERIAL AS A TREATMENT FOR HIV
Chang Raymond Y, Kong XB**. *Cornell Medical College, NewYork, NY USA;**New
York University, New York NY USA
Objective:To identify the current scope and nature of plant and herbal compounds and
extracts potentially useful in anti-HIV treatment, and their state of research and development.
Methods: A comprehensive search of the published literature since 1982 on all plant and
herbal compounds or extracts screened for anti-HIV activity and applied to AIDS therapy

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