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.
Study Type
OBSERVATIONAL
Enrollment
860
All participants will undergo neurological examinations and neuropsychological assessments.
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
Rio de Janeiro, Brazil
YRG Center for AIDS Research and Education
Chennai, India
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Dr. Kotnis Dispensary
Pune, India
National AIDS Research Institute (NARI) ICMR
Pune, India
National Institute of Virology (NARI)
Pune, India
The Johns Hopkins-Malawi College of Medicine Project
Blantyre, Malawi
University of North Carolina Project (UNC Project)
Lilongwe, Malawi
University of KwaZulu Natal
Durban, KwaZulu-Natal, South Africa
University of Witwatersrand
Johannesburg, South Africa
...and 1 more locations