Immune Reconstitution in naïve HIV Patients With CD4 <100 Cells/mL When Treated With Lopinavir or Efavirenz.

A Randomized, Pilot Study on the Antiviral Activity and Immunological Effects of Lopinavir/Ritonavir vs. Efavirenz in Treatment-naïve HIV-Infected Patients With CD4 Cell Counts Below 100 Cells/mm3

Pilot, randomized, parallel, open-label, controlled, clinical study evaluating virological response in plasma and extra-plasmatic compartments, together with the degree and kinetics of immune reconstitution in treatment-naïve patients with CD4 count below 100 cells/mL, when treated with tenofovir and abacavir together with lopinavir or efavirenz.

Inclusion Criteria:

• HIV-infection
• Antiretroviral-naive
• CD4 cell count below 100 cells/mm3

Exclusion Criteria:

• Pregnancy
• Current opportunistic infection requiring parenteral therapy
• Current malignancies requiring parenteral chemotherapy
• Any contraindication to the study drugs