AEGiS-15IAC: Clinical trial on the feasibility and the imuno-virologic efficacy and safety of Fortovase/Ritonavir regimen in Resource-Limited Settings: Case of Senegal.

3, ARV therapy naïve and who accepted after informent consent" /> AEGiS-15IAC: Clinical trial on the feasibility and the imuno-virologic efficacy and safety of Fortovase/Ritonavir regimen in Resource-Limited Settings: Case of Senegal.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Clinical trial on the feasibility and the imuno-virologic efficacy and safety of Fortovase/Ritonavir regimen in Resource-Limited Settings: Case of Senegal.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. B10343)

Ndiaye I, Sow PS, Gueye NF, Diouf LM, Gueye PM, Bassene E, Kane NC, Diaw A, Mboup S
Hospital, Dakar, Senegal

OBJECTIVE: Determine the feasibility of this treatment. Determine clinical efficacy and safety of this therapy. Methodology: This a prospective open study for 96 weeks, including subjects with HIV1+, over 18 years old at B or C stage with CD4 less 350cells/mm³, ARV therapy naïve and who accepted after informent consent. The antiretroviral combination is; Fortovase 1600mg QD/ Ritonavir100mg QD and Combivir® BID. The following care was monthly during the 3 first, so all 3 months with a clinical and immuno-virologic assessment. A psychosocial care support was insured by Social Worker. Cool Boxes used for to keep on to fresh Fortovase and Ritonavir. Questionnaires used for to collect data concerning the adherence of therapy and assessment of the quality of life. Cases Report Form served for to collect clinical and laboratory data.

RESULTS: Fifty patients are included from 2001 to 2003. A good virologic response has been noted with 70% patients with Viral Load below 400copies/ml at Week 24; 80% at Week 48 and 85% at Week 96. The average CD4 increase gradually from beginning (194cells/mm³), with 267cells/mm³ at Week 24; 298cells/mm³ at Week 48 and 354/mm³ at Week 72. So, eight subjects have a sub optimal virologic response related to adherence to therapy, lack of observance and preservation in a cool place of Fortovase and Ritonavir. The safety of drugs was acceptable with some minor sides effects; anemia(9 cases); neutropenia(3) and gastric intolerance( vomiting, nausea, diarrhea). Fourth patients are died, and three abandonments are been registered. Improvement of quality life has been noted, with a gain of weight; capacity of work; decreasing of Opportunistic Infections.

CONCLUSION:The feasibility of the heaviness regimen has been proved with a good proportion of subjects who continued the study at term(85%). But A psychosocial and social care support, by regular education of patients, is necessary for a good adherence to therapy.

Keywords: AEGIS, Ritonavir, Saquinavir, Viral Load, Clinical Trials, HIV-1, Lamivudine, Zidovudine, Safety, Prospective Studies, Senegal, Combivir, Humans, virology

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