An open label clinical trial was designed to analyze if a four-drug combination that includes two protease inhibitors (PIs) accelerates viral decay and suppression as compared with standard triple therapy in heavily immunosuppressed HIV patients.

PI-naive patients receiving their first HAART 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 [Fortovase]) or two PIs (saquinavir + nelfinavir [Viracept]).

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.

Conclusions

No viral variable was significantly 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 viral load.

Unit of Infectious Diseases, Hospital General Universitario de Alicante, Spain.

01/17/06

Reference
J Portilla and others. 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. International Journal of STDs and AIDS 16(12): 807-810. December 2005.

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