Quadruple-2 protease inhibitors (PI)-therapy does not accelerate viral decay and suppression in PI-naive HIV-1 infected patients with severe immunosuppression and high viral load as compared with standard triple therapy.
To analyse if a four-drug combination including two protease inhibitors (PIs) accelerates viral decay and suppression as compared with standard triple therapy in heavily immunosuppressed HIV-1 infected patients, an open label clinical trial was designed. PIs naive patients receiving their first highly active antiretroviral therapy were included if their CD4 cell count was lower than 200/mm3 and their HIV viral load (VL) >100,000 RNA copies/mL. Every patient received two analogues and was randomized in two groups receiving either one PI (saquinavir soft gel capsule) or two PIs (saquinavir + nelfinavir). Viral efficacy (VL <50), time to reach VL <50, viral clearance rate constant and plasmatic elimination half-life were determined. In all, 30 patients were enrolled. No viral variable was significatively improved by the four-drug combination in the short term. No clinical benefit should be expected with a four-drug (two PIs) regimen in patients with low CD4+ cell count and high VL.
Portilla
Joaquín
J
Unit of Infectious Diseases, Hospital General Universitario de Alicante, Spain.
Boix
Vicente
V
Garcia-Henarejos
José Antonio
JA
Llopis
Coral
C
Martínez-Madrid
Onofre
O
Gimeno
Adelina
A
Sánchez-Paya
José
J
Merino
Esperanza
E
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015497:HIV-1 / Q000187:drug effects* / Q000502:physiology; D006801:Humans; D007165:Immunosuppression Therapy; D019888:Nelfinavir / Q000008:administration & dosage* / Q000009:adverse effects; D019258:Saquinavir / Q000008:administration & dosage* / Q000009:adverse effects; D019562:Viral Load
D017320:HIV Protease Inhibitors; D019888:Nelfinavir; D019258:Saquinavir