AEGiS-15IAC: IMANI-1 TC3WP Single drug HAART- proof of concept study. Pilot study of the safety and efficacy of Kaletra (LPV/r) as single drug HAART in HIV + ARV-naïve patients-interim analysis of subjects completing final 48 week data.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

IMANI-1 TC3WP Single drug HAART- proof of concept study. Pilot study of the safety and efficacy of Kaletra (LPV/r) as single drug HAART in HIV + ARV-naïve patients-interim analysis of subjects completing final 48 week data.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. MoOrB1057)

J C Gathe, Jr.¹, M Y Washington¹, C Mayberry², D Piot², J Nemecek²
¹Therapeutic Concepts, PA, Houston, United States; ²Donald R. Watkins Memorial Foundation, Houston, United States

BACKGROUND: Single agent therapy effective for virologic control could preserve future treatment options; help delineate safety/toxicity issues of individual drugs as compared to combination therapy.

METHODS: 48 week open label proof of concept single site study in ARV naïve patients with VL >2000 and no CD4 entry criteria. Intensification at any point with either TDF/3TC or SQV was allowed. Primary endpoint - % of subjects< 400 copies at 48 weeks and the incidence of AE. Secondary endpoints - % of subjects< 50 copies and CD4 count changes.

RESULTS: 30 patients (mean VL 262,000, CD4 169) began treatment with LPV(r) dosed 3 or 4 caps bid based on weight. At 48 weeks 11 subjects were non-completers. LTFU (2), AE (2), non-adherent (2), deported (1), virologic failure (3), hepatitis B (1). On ITT NC=F analysis 19/30 patients were< 400 (58%), 16/30 patients< 50 copies (54%). Genotypic/phenotypic resistance was not seen CD4 [up arrow] mean 228. Significant AE's were not seen.

CONCLUSIONS: LPV(r) as single agent therapy exhibited virologic efficacy comparable to combination PI therapy. Response was not compromised by high % of advanced disease subjects; lack of funding for the study. Significant toxicity was not seen. Genotypic/phenotypic resistance was not seen. LPV(r) as single agent therapy should be evaluated further in controlled study.

Keywords: AEGIS, HIV, Acquired Immunodeficiency Syndrome, Antiretroviral Therapy, Highly Active, Pyrimidinones, HIV Seropositivity, Pilot Projects, HIV Infections, HIV Protease Inhibitors, Single Person, CD4 Lymphocyte Count, Anti-HIV Agents, Lamivudine, Pharmaceutical Preparations, lopinavir, Humans

040711
MoOrB1057