A5199

BACKGROUND AND STUDY OBJECTIVES

The neurological disease in HIV is AIDS Dementia (primary) and CNS Opportunistic Infections (secondary). The prevalence and incidence of these diseases are unknown in international resource limited settings.

To estimate:

  • Prevalence, incidence of primary HIV neurological disease (AIDS Dementia)
  • Prevalence, incidence of neurological opportunistic infections
  • Changes in neurocognitive functioning with antiretroviral treatment

Secondary Objectives:

  • Changes in quality of life/loss of productivity
  • Association between treatment failure and neurological dysfunction
  • Association between high viral load and neurological dysfunction
  • Association between CNS side effects and EFV treatment
  • Peripheral neuropathy and increase in the ‘d’ drug arms
  • CNS penetration over non penetrating regimens 

SITES PARTICIPATING IN THE A5199 STUDY

  • Rio de Janeiro, Brazil
  • Porto Alegre, Brazil
  • Port-au-Prince, Haiti
  • Chennai, India
  • Pune, India
  • Blantyre, Malawi
  • Lilongwe, Malawi
  • Lima, Peru
  • Johannesburg, South Africa
  • Durban, South Africa
  • Chiang Mai, Thailand
  • Harare, Zimbabwe

POPULATION AND ELIGIBILITY:

Co enrolled in 5175, CD4 +300, Treatment naive

EVALUATIONS:

  • Neurological Diagnoses
  • Neuropsychological functioning

Primary endpoints

  • Presence or absence of ADC
  • Presence or absence of neurological OIs (Appendix 60)
  • Changes from baseline in neurocognitive function at follow-up
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