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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00096824 |
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.
Condition | Intervention |
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HIV Infections |
Behavioral: Neurological assessment |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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) |
Estimated Enrollment: | 960 |
Study Start Date: | February 2006 |
Groups/Cohorts | Assigned Interventions |
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1
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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Behavioral: Neurological assessment
All participants will undergo neurological examinations and neuropsychological assessments.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All participants who enrolled in ACTG study 5175
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz | |
Rio de Janeiro, Brazil, 21045-900 | |
Brazil, RS | |
Hospital Nossa Senhora da Conceicao | |
Porto Alegre, RS, Brazil, 91350-200 | |
India | |
National AIDS Research Institute (NARI) ICMR | |
Pune, India, 411026 | |
Dr. Kotnis Dispensary | |
Pune, India, 411026 | |
National Institute of Virology (NARI) | |
Pune, India, 411026 | |
YRG Center for AIDS Research and Education | |
Chennai, India, 60001-7 | |
Malawi | |
University of North Carolina Project (UNC Project) | |
Lilongwe, Malawi | |
The Johns Hopkins-Malawi College of Medicine Project | |
Blantyre, Malawi | |
South Africa | |
University of Witwatersrand | |
Johannesburg, South Africa | |
South Africa, KZN | |
University of KwaZulu Natal | |
Durban, KZN, South Africa, 4013 | |
Zimbabwe | |
University of Zimbabwe | |
Harare, Zimbabwe |
Study Chair: | Kevin Robertson, PhD | Department of Neurology, University of North Carolina at Chapel Hill |
Study Chair: | Johnstone Kumwenda, MD, MBBS, MMED | Internal Medicine, Johns Hopkins Project |
Study Chair: | Khuanchai Supparatpinyo, MD | Research Institute for Health Sciences, Chiang Mai University |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG A5199 |
Study First Received: | November 15, 2004 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00096824 |
Health Authority: | United States: Federal Government |
Acute Infection Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Dementia Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |