AEGiS-13IAC: Use of the plant E-Sitosterol/E-Sitosterol glucoside mixture (Moducare) for the management of South African HIV infected individuals: an open-labelled study over 40 months.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Use of the plant E-Sitosterol/E-Sitosterol glucoside mixture (Moducare) for the management of South African HIV infected individuals: an open-labelled study over 40 months.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB538)

Bouic P, Lamprecht J, Freestone M
P. Bouic, University of Stellenbosch, Dept. Medical Microbiology, Tygerberg Hospital, PO Box 19063, Tygerberg 7505, South Africa, Tel.: +27 21 938 4035, Fax: +27 21 938 4005, E-mail: pjdb@gerga.sun.ac.za

BACKGROUND: Results in vitro using a mixture of BSS and BSSG showed that these had immunomodulatory activities (enhancement of IFN-g and IL2 secretion) whilst decreasing the levels of IL6 and TNF-α. An open-labeled study was initiated to test this mixture in HIV infected individuals not on any forms of therapy.

METHODS: 123 HIV positive patients were recruited to participate in this open trial and they were stratified according to their baseline CD4 cell numbers: CD4 > 200 cells/uL (n = 10): CD4 200-500 cells/uL (n = 66) and CD4 > 500/uL (n = 47). The patients were given the capsules of ModucareTM and bloods were drawn for routine hematology, chemistry, CD4 cell determinations by flow cytometry and viral load assay by NASBA. The patients were allowed free access to supportive medication should they have required it for any HIV related complications.

RESULTS: Complete data for all patients over a period of 39 months are currently available. The median CD4 cell number for the group of patient > 200 cells/uL showed a significant decline in CD4 % and absolute numbers (p = 0.0001) with their viral loads showing a slight but non significant increase over the time period (p = 0.41). Group 2 (CD4 200-500/uL) showed no significant change in their CD4 cells (% and absolutes) with the viral loads remaining unchanged over the baseline median value (NS). Group 3 (CD4 > 500/uL) showed a significant increase in CD4 cell % and absolute numbers (p = 0.034) with a significant decline in the viral loads (p = 0.038). Within this group, 15% (7/47) showed undetectable viral loads within 12 months after starting the study: this was sustainable.

CONCLUSIONS: The natural plant sterols/sterolins could represent an important management strategy for African HIV infected individuals in the absence of any official treatment policy, especially in recently infected and immune intact patients.

Keywords: AEGIS, HIV, HIV Infections, Viral Load, Sitosterols, CD4-Positive T-Lymphocytes, Anti-HIV Agents, HIV Seropositivity, Phytosterols, HIV Protease Inhibitors, sitosterol, In Vitro, Human, pathogenicity, organization & administration
000709
WeOrB538