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

12th World AIDS Conference

Abstracts 60366-60371 1067

S60366 Using developmental evaluation to build national
capacity to respond to the HIV epidemic
Bruce Parnell1, E.A. Reid2. 1Macfarlane Burnet Centre for Med. Res., Yarra Bend
Road, Fairfield 3078, Australia; 2Senior Adviser, BDP UNDP, New York, NY USA
Issues: Developmental evaluation is a systemic and on-going learning process
for the purpose of programme and/or organisational development. This paper
reports on how a process of evaluation design enabled stakeholders to draw on
their own understanding of how social change comes about in their setting and
to apply that understanding to respond to the epidemic.
Project: The programme, UN Volunteer (UNV) Support to People Living with
HIV and AIDS, aims to facilitate the involvement of people living with HIV and
AIDS in the national response in Malawi and Zambia. The operational question
was: How can a monitoring and evaluation framework be designed which will help
further the process of programme development and provide the data required for
later summative evaluations.
Results: The design process brought together all the stakeholders to discuss
and clarify from their various perspectives the programme's objectives, to cosider
how the programme can and cannot contribute to the achievement of these objectives and to identify a range of processes achievable within current human and
financial resources which could constitute a monitoring and evaluation framework
at this stage of programme development. The processes of clarification, inclusion,
accepting and addressing differences, and of learning from others led to increased
engagement, constituency building and commitment to the programmes approach
and intended outcomes.
Lessons Learned: A monitoring and evaluation framework can be generated
by stakeholders through inclusive facilitated processes of reflection and the sharing of experiences and insights. These processes enhance the likelihood that the
framework will beimplemented and that the evaluation data will be relevant.
60367 Severe cortisol deficiency related to high dose megestrol
acetate therapy
Shurjeel Choudhri1, E.A. Salamon2, J.R.M. Smith3. 1C5124-409 Tache Avenue,
Winnipeg, Manitoba; 2University of Manitoba, Winnipeg, MB; 3 Village Clinic,
Winnipeg, MB, Canada
Background: Severe cortisol deficiency is a rare complication of HIV infection.
There is evidence that megestrol acetate (Megace) can suppress the pituitaryadrenal axis and cause or unmask cortisol deficiency. We describe three cases
where the presence of severe cortisol deficiency was unmasked by the initiation
of megace therapy.
Case Reports: Pertinent patient details are given in the table. All three patients
were started on Megace 800 mg od for treatment of wasting. All were on highly
active antiretroviral therapy and all developed cortisol deficiency within one month
of starting therapy.
Case Age CD4 Count (mm3) Cortisol (nmol/L) Associated Findings
1 42 25 13 Altered skin color
2 31 123 13 Hyponatremia
3 42 28 42 Chronic diarrhea
Only case 1 had a change in skin pigmentation. Case 2 presented with hyponatremia and an electrolyte picture consistent with the syndrome of inappropriate
antidiuretic hormone excess (SIADH). All three patients had wasting manifested
by diarrhea and weight loss >10% of ideal body weight. All responded promptly
to oral hydrocortisone therapy.
High dose Megace therapy may cause or unmask severe cortisol deficiency in
patients with advanced HIV infection. Such patients should have an ACTH stimulation test to rule out pre-existing cortisol deficiency prior to initiating Megace
therapy.
60368 Prevalence of malnutrition in a cohort of HIV+ men:
Seron AIDS Study Group experience
Mark Scheperle1, M.J. Scolaro1, A.E. Fisher2, R.C. Scott3, K.M. Fisher4,
J. Glaser5, N. Muurahainen6. First Family Medical Group; 1University Medical
Specialist, St. Louis, MO 63117; 2Beverly Hills, CA; 3Stratogen Health,
Providence; 4 Oakland, CA; 5Phoenix, AZ; 6Staten Island, NY; 7Serono
Laboratories Norwell, MA, USA
Objectives: A prospectively collected patient registry (SeronAIDS) was used
to investigate the prevalence of AIDS wasting in a defined population of HIV+
patients (pts).
Design: Prospective cross-sectional study with descriptive and analytic components
Methods: Data was collected from 25 sites across the US and included age,
height, weight, antiretroviral regimen and CD4 counts. Ideal body weight (IBW)
and body mass index (BMI) were calculated from height and weight, and body
cell mass (BCM) was calculated using bioelectrical impedance measurements.

Baseline data was collected between 4/97 and 9/97 on 166 pts. Analysis was
done on 152 male pts.
Results: Mean age at baseline (n = 152) was 39.8 years (range 27.0 to 65.0
years). Mean CD4 count (n = 138) was 245 cells/mm3 with a minimum of 0 and
a maximum of 1169 cells/mm3. CD4 counts were less than 50 cells/mm3 for 31
pts (22.5%), 50 to 199.9 cells/mm3 for 39 pts (28.3%), 200 to 499.9 cells/mm3
for 52 pts (37.7%) and >500 cells/mm3 for 16 pts (12.2%). 128 out of 152 pts

(84.2%) were on protease inhibitors at baseline, and 141 of 151 pts (93.4%) were
on some kind of antiretroviral therapy. 107 of 152 pts (70.4%) had taken caloric
supplements within the 12 months prior to their baseline visit, while 87 (57.2%)
were taking them at baseline. 48 of 141 pts (34.0%) were -90% of their IBW, 23
pts (16.3%) had IBW:> 90% and -95%, and 70 pts (49.6%) had IBW. 95% at
baseline. 31 (22%) of these pts had BMI - 20, 12 (8.5%) at least 20 and - 21,
20 pts (14.2%) at least 21 and <22, and 78 (55.3%) 22 or greater. BCM (n = 90)
ranged from 36.9 to 94.9 kg with a mean of 63.9 kg.
Conclusions: In spite of different antiretroviral modalities used in this cohort
of HIV+ patients the plevalence of wasting was high (IBW - 90% in 34.0% of
patients, BMI < 21 in 30.5%). Future prospective data from this registry will reveal
how the use of Serostim and other therapies for AIDS wasting affect the clinical
outcome and quality of life of this patient population.
60369 Treatment of HIV/AIDS cases with Immuno-potentiators
and protection of the fetus in pregnant women
Surendra Rohatgi. Hind Chemicals Limited M-336 Rail Bazar Kanpur-208004,
India
Objectives: To assess the efficacy of a therapy based on immuno-modulators in
cases of HIV/AIDS.
Design: Clinical trials on confirmed HIV cases of different stages.
Methods: Cases of HIV confirmed by Western-blot were included in the study
and their CD4 counts estimated. The patients were given IMMINEX, a plant
based immuno-modulator and LIVZON, a hepato-protective agent which stimulates physiological functions as per US patent No. 5,529,778 of June 25, 1996.
All other conventional drugs for the treatment of AIDS and opportunistic infections were withdrawn. Treatment of symptoms such as diarrhoea and pulmonary
congestion were treated with well known herbal drugs which have no immunosuppressive side effect. Periodical CD4 counts were estimated and when the
counts reached the optimum level of 1000 (or 1500 for the new born) P24 Ag was
estimated, followed by PCR. Pregnant women were put on the therapy to prevent
vertical transmission and the new born given the drugs in syrup form.
Conclusion: A total of 25 patients have been treated so far. The CD4 counts
reached the normal level within a month or so. Antibiotics, sulphas and other
conventional drugs which have immuno suppressant effect were found to depress
the CD4 count and are contra-indicated. The therapy can protect the fetus as
also the new born.
60370 In vitro anti-HIV-1 and HIV-2 virucidal properties of the
F-5" gel, a potentially new vaginal microbicide for STD
prevention
Patrick Colin', L. Thibodeau2, C. Tremblay2, C. Sauriol3. 1597 Laurier
Boulevard, Mont-St-Hilaire, Quebec, J3H 4X8; 2Armand Frappier Institute AIDS
Lab; 3Biopharm Laboratories, Laval, Quebec, Canada
Objectives: The F5" gel, used in the Protectaid' vaginal contraceptive sponge,
contains the 3 spermicidals nonoxynol-9, benzalkonium chloride and sodium
cholate at very low concentrations. In order to assess the STD microbicidal
potential of the gel, its anti HIV-1 and HIV-2 virucidal effects were evaluated in
vitro.
Methods: HIV-1 and HIV-2 viral stocks were prepared from syncitia inducing
laboratory strains (LAI and ROD) cultured on CD4+ CEM cells, in RPMI 1640. The
titers obtained were 1075 TCID5s/mL for HIV-1, and 1081 TCIDso/mL for HIV-2.
Typical cytopathic effects were observed at dilutions up to 106 for HIV-1 and 107
for HIV-2. F-5" gel diluted 10,100 and 1000 times, as well as a RPMI control,
were incubated at 37 C for 1 hour with decimal dilutions of the HIV-1 and HIV-2
viral stocks. Cristals and insoluble material were eliminated by centrifugation,
and supernatants were diluted and ultracentrifugated to obtain F-5' gel free viral
samples. A morphological assessment of the effects of the gel on the virus was
done by electronic microscopy (SEM). Residual HIV infectivity was also assessed
by infecting 2 x 106 CEM cells. Cythopathic effects were monitored daily during
7 days after which titers were determined. Finally, HIV-1 and HIV-2 antigens
expression by CEM cells was evaluated by indirect immunofluorescence.
Results: Significant morphological effects on the virus were observed at all
gel dilutions, while there was no effect with the control. These effects were
more important against HIV-1 than HIV-2. With HIV-1, residual infectivity was
completely abolished, and less than 1% of CEM cells expressed antigens. Under
identical experimental conditions, HIV-2 was 5,000 times less sensitive to the gel.
However, a 10 fold dilution of the gel could still inactivate more than 4 log of HIV-2
(10,000 TCID50o).
Conclusion: This study showed that F-5" gel has very significant anti HIV-1
and HIV-2 virucidal properties. The anti-HIV-1 effects are greater, with the capacity
to inactivate up to 50 millions infectious units even at a 1000 fold dilution of the
gel. These promissing findings need to be confirmed in vitro with primary isolates.
as well as clinically in high risk women.

S60371 Pentoxifylline for the treatment of aphtous ulcers in HIV
patients
Alain Landau, G. Pialoux, M. Eliaszewicz, L. Aaron, B. Dupont. 209 Rue de
Vaugirard, 75015 Paris, Pasteur Hospital, Paris, France
Objectives: Recurrent aphtous ulcerations in patients with human immunodeficiency virus (HIV) are a painful HIV complication. All the gastroinstestinal tract