Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurological assessment | Behavioral | All participants will undergo neurological examinations and neuropsychological assessments. |
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All participants who enrolled in ACTG study 5175
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil | ||
| Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12707852 | Background | Albright AV, Soldan SS, Gonzalez-Scarano F. Pathogenesis of human immunodeficiency virus-induced neurological disease. J Neurovirol. 2003 Apr;9(2):222-7. doi: 10.1080/13550280390194073. | |
| 12707851 | Background | McArthur JC, Haughey N, Gartner S, Conant K, Pardo C, Nath A, Sacktor N. Human immunodeficiency virus-associated dementia: an evolving disease. J Neurovirol. 2003 Apr;9(2):205-21. doi: 10.1080/13550280390194109. |
| Label | URL |
|---|---|
| Click here for more information about the ACTG A5175 study | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Rio de Janeiro |
| 21045-900 |
| Brazil |
| YRG Center for AIDS Research and Education | Chennai | 60001-7 | India |
| Dr. Kotnis Dispensary | Pune | 411026 | India |
| National AIDS Research Institute (NARI) ICMR | Pune | 411026 | India |
| National Institute of Virology (NARI) | Pune | 411026 | 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 | 4013 | South Africa |
| University of Witwatersrand | Johannesburg | South Africa |
| University of Zimbabwe | Harare | Zimbabwe |
| 12491162 | Background | Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. doi: 10.1080/13550280290101094. |
| 11935465 | Background | Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. doi: 10.1080/13550280290049615. |
| 40321763 | Derived | Michael H, Rapulana A, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual Trajectories of Serum Brain-Derived Neurotrophic Factor and Cognitive Function in People Living with HIV. Res Sq [Preprint]. 2025 Apr 14:rs.3.rs-4307577. doi: 10.21203/rs.3.rs-4307577/v1. |
| 40319152 | Derived | Michael HU, Rapulana AM, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F. Dual trajectories of serum brain-derived neurotrophic factor and cognitive function in people living with HIV. Sci Rep. 2025 May 3;15(1):15520. doi: 10.1038/s41598-025-99569-6. |
| 30219843 | Derived | Robertson KR, Jiang H, Kumwenda J, Supparatpinyo K, Marra CM, Berzins B, Hakim J, Sacktor N, Campbell TB, Schouten J, Mollan K, Tripathy S, Kumarasamy N, La Rosa A, Santos B, Silva MT, Kanyama C, Firhnhaber C, Murphy R, Hall C, Marcus C, Naini L, Masih R, Hosseinipour MC, Mngqibisa R, Badal-Faesen S, Yosief S, Vecchio A, Nair A; AIDS Clinical Trials Group. Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings. Clin Infect Dis. 2019 May 2;68(10):1733-1738. doi: 10.1093/cid/ciy767. |
| 30137250 | Derived | Robertson KR, Oladeji B, Jiang H, Kumwenda J, Supparatpinyo K, Campbell TB, Hakim J, Tripathy S, Hosseinipour MC, Marra CM, Kumarasamy N, Evans S, Vecchio A, La Rosa A, Santos B, Silva MT, Montano S, Kanyama C, Firnhaber C, Price R, Marcus C, Berzins B, Masih R, Lalloo U, Sanne I, Yosief S, Walawander A, Nair A, Sacktor N, Hall C; 5199 Study Team; and the AIDS Clinical Trials Group. Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction. Clin Infect Dis. 2019 May 2;68(10):1739-1746. doi: 10.1093/cid/ciy718. |
| 22661489 | Derived | Robertson K, Jiang H, Kumwenda J, Supparatpinyo K, Evans S, Campbell TB, Price R, Tripathy S, Kumarasamy N, La Rosa A, Santos B; 5199 study team; Silva MT, Montano S, Kanyama C, Faesen S, Murphy R, Hall C, Marra CM, Marcus C, Berzins B, Allen R, Housseinipour M, Amod F, Sanne I, Hakim J, Walawander A, Nair A; AIDS Clinical Trials Group. Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group study a5199, the International Neurological Study. Clin Infect Dis. 2012 Sep;55(6):868-76. doi: 10.1093/cid/cis507. Epub 2012 Jun 1. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided