There are 2 clinical trials
Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.
- Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M. --- L10F --- --- K20M --- --- M36I --- --- I54L --- --- L63P --- --- A71T --- --- V82A --- --- I84A ---
This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies
- Ability and willingness to provide written informed consent and adhere to the study regimen - Females of childbearing potential must have a documented negative serum or urine pregnancy test at screening/baseline and ensure that 2 reliable forms of contraception are being used, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication Exclusion Criteria: - Documented virological failure on a protease inhibitor ARV regimen prior to commencing Kaletra® regimen - Documented protease mutation (one or more from the following list) prior to commencing Kaletra® regimen: - M46I/L/V, I47A/V, G48V/M, I50V, F53L/Y, I54L/M/V/A/T/S, V82A/T/S/F/M/L, I84A/V/C, L90M - Patients with acute hepatitis B or C infection - Females who are pregnant, breast-feeding, or who plan to become pregnant or breast-feed during the study· - Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis) Note: The site will calculate each patient's CrCl using the Cockcroft-Gault formula  as shown below: CrCl = [140 - age (yr)] × weight (kg) × constant 72 × serum creatinine (Cr) (mg/dL) where, constant = 1 for men and 0.85 for women - Any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 4). --- M46I --- --- I47A --- --- G48V --- --- I50V --- --- F53L --- --- I54L --- --- V82A --- --- I84A ---