AEGiS-14IAC: A pilot study of saquinavir-SGC (Fortovase, SQV) 1000mg and lopinavir /ritonavir (LPV/r) twice daily in protease inhibitor naïve (PIN) HIV+ individuals.

14th International AIDS Conference

Barcelona, Spain - July 7-12, 2002

A pilot study of saquinavir-SGC (Fortovase, SQV) 1000mg and lopinavir /ritonavir (LPV/r) twice daily in protease inhibitor naïve (PIN) HIV+ individuals.

Int Conf AIDS 2002 Jul 7-12; 14:(abstract no. B10347)

Hellinger J, Cohen CJ, Morris AB, Hall SS, Jackson-Pope L, de Caprariis PJ
Community Research Initiative of New England, Boston and Springfield, MA, United States

BACKGROUND: Four yr followup of the RTV/SQV study (ABT 462) showed sustained viral suppression in 39 PI naïve subjects with NRTI intensification and in 44 with no intensification. Lipoatrophy was significantly more prevalent in subjects on NRTIs. OBJECTIVES: To evaluate the Cmin, safety & antiviral activity in PI naïve subjects when SQV 1000 mg plus LPV/r 400 mg/100 mg BID with no NRTIs.

METHODS: Open label 48 week study of safety and antiviral activity in subjects with HIV RNA viral load (VL) >1000 c/ml with intensification after week 12 according to VL response. All subjects initiated SQV 1000mg BID; if intolerant, the dose was reduced to 600 BID with escalation as tolerated to 1000 mg BID.

RESULTS: 12 enrolled. Male 92%, African American 25%, MSM 83%; Mean age 43 yrs. Log VL 4.17; median VL 28,625c/ml; CD4=210 mm3. Prior NRTI use 92%; prior NNRTI use 25%. 50% required initial SQV dose reduction to 600 mg due to gastrointestinal intolerance, and then dose escalation or substitution INV (n=1). No subject discontinued prematurely for adverse events, and all remain on study. To date, 9 subjects have reached week 4, and 8 subjects have reached week 12. At week 4, 89% have VL<400 c/ml, and 22% are <50 c/ml. At week 12, 100% have VL <400 c/ml and 75% are <50 c/ml. The 2 subjects not <50 c/ml have VLs of 100 and 104 c/ml. CD4+ cell counts increased a mean 67 cells/mm³ at week 4, and 147 cells/mm³ at week 12. No subjects have required nucleoside intensification.

CONCLUSIONS: In this small pilot study, preliminary data indicate brisk VL suppression and CD4 response, with no subjects requiring nucleoside intensification to date. Early tolerance and adherence to SQV sgc and LPV/r may be improved by dose escalation from SQV sgc 600 to 1000 mg twice daily. 24 week data including 12 hour Cmin drug levels obtained for SQV and LPV, sequential lipid values and lipodystrophy assessments will be presented.

Keywords: AEGIS, Saquinavir, Ritonavir, HIV, HIV Infections, Pyrimidinones, HIV Protease Inhibitors, Protease Inhibitors, Anti-HIV Agents, CD4 Lymphocyte Count, HIV Seropositivity, lopinavir, Male

020707
B10347