Intermittent Therapy in HIV-1 Infected Patients With Successful Viral Suppression Under Highly Active Antiretroviral Therapy (HAART)

• Immunological failure, defined by a CD4 cell count below 300/µl confirmed by a retest 14 days later during the study
  

• 1993 Centers for Disease Control (CDC) classification of HIV infection B or C events
  
• Proportions of patients with CD4 count over 450/µl at week 96
  
• Proportions of patients with plasma HIV load over 400 and 1000/ml thresholds
  
• Plasma and peripheral blood mononuclear cells (PBMC) HIV resistance patterns
  
• Proportions of patients withdrawing initial treatment strategy
  
• Assessment of lipodystrophy and metabolic abnormalities
  
• Antiretroviral therapy (ARTs) adherence assessment
  
• Quality of life assessment
  
• Cost impact of the strategies
  

Although lifelong continuous therapy with HAART remains the standard of care of HIV infection, allowing to achieve undetectable plasma viral RNA, restore CD4 cell count and provide substantial decline in HIV-related morbidity and mortality, long-term toxicity associated with antiretroviral therapy is a real concern.

The purpose of this study is to compare an intermittent therapy (IT) strategy (8 weeks off / 8 weeks on) to a continuous treatment (CT) in patients with chronic and well controlled HIV-1 infection (CD4 over 450/µl and plasma HIV1-RNA below 200 cp/ml) under HAART, over a 96-week study period.

The study hypothesis is that intermittent therapy is not inferior to continuous therapy in maintaining a CD4 cell above 300/µl. It will compare the proportions of and time to immunological failure (CD4 count below 300/µl confirmed by a retest 14 days later) in the IT and CT groups.