HIV Infections Clinical Trial
Official title:
International Neurological Study: A Stand Alone Study for Participants of A5175 (A Phase IV, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combination for Initial Treatment of HIV-1 Infected Individuals From Diverse Areas of the World)
The purpose of this study is to determine how often dementia and other neurological problems occur in people with HIV. Participants of ACTG A5175 will enroll in this study.
Both the central and peripheral nervous systems (CNS and PNS) are affected by HIV; however,
the causes of neurotoxicity in HIV infected patients are unknown. Initial data indicate that
as many as 40% of patients with HIV develop some form of dementia. Other common neurological
problems observed in HIV patients are peripheral neuropathy and opportunistic infections of
the CNS. Most antiretroviral drugs used in the treatment of HIV have poor penetration into
the CNS, which may explain how HIV persists in the CNS and contributes to the prevalence of
dementia and other neurological disorders in HIV infected patients. This study will examine
the prevalence of dementia and other neurological disorders in participants in ACTG A5175,
"Once-Daily PI/NNRTI Therapy Combinations for Treatment Naive, HIV Infected Patients in
Resource-limited Conditions."
The study will last approximately 2.5 to 3 years. Participants will undergo neurological
examinations and neuropsychological assessments at entry to both steps of ACTG A5175 and
before the administration of the new antiretroviral regimen, then every 24 weeks until they
discontinue ACTG A5175. Physicians will make targeted diagnoses at each study visit.
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Observational Model: Cohort, Time Perspective: Prospective
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