A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175

NCT00096824 | Completed DMC

• 2 other identifiers: ACTG A51991U01AI068636
• Study Type: observational
• Target: 860
• Locations: 5 countries
• Sites: 11

Brief Summary

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.

Conditions

HIV Infections

Keywords

Acute Infection; Treatment Naive

Study Arms (1)

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.

Behavioral: Neurological assessment

Interventions

Neurological assessment BEHAVIORAL

All participants will undergo neurological examinations and neuropsychological assessments.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants who enrolled in ACTG study 5175

You may qualify if:

• HIV-1 infected
• Prior antiretroviral therapy for less than 7 days any time prior to study entry
• CD4 count less than 300 cells/mm3
• Willing to use acceptable means of contraception
• Plans to stay in the area for the duration of study participation
• Willing to adhere to study follow-up schedule for ACTG A5175 and this study
• Have not begun ACTG A5175 antiretroviral therapy, but planning to start therapy after enrolling in this study

You may not qualify if:

• Any active severe psychiatric illness (e.g., schizophrenia, severe depression, severe bipolar affective disorder) that, in the opinion of the site investigator, may interfere with the study results
• Current drug or alcohol abuse that, in the opinion of the site investigator, would interfere with study requirements
• Serious illness or hospitalization that, in the opinion of the site investigator, may interfere with the study results
• Any condition that, in the opinion of the site investigator, would interfere with study requirements

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (11)

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz

Rio de Janeiro, 21045-900, Brazil

Location

YRG Center for AIDS Research and Education

Chennai, 60001-7, India

Location

Dr. Kotnis Dispensary

Pune, 411026, India

Location

National AIDS Research Institute (NARI) ICMR

Pune, 411026, India

Location

National Institute of Virology (NARI)

Pune, 411026, India

Location

The Johns Hopkins-Malawi College of Medicine Project

Blantyre, Malawi

Location

University of North Carolina Project (UNC Project)

Lilongwe, Malawi

Location

University of KwaZulu Natal

Durban, KwaZulu-Natal, 4013, South Africa

Location

University of Witwatersrand

Johannesburg, South Africa

Location

University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (9)

• 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.

  PMID: 12707852 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.

  PMID: 12707851 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.

  PMID: 12491162 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.

  PMID: 11935465 BACKGROUND

• 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.

  PMID: 40321763 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.

  PMID: 40319152 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.

  PMID: 30219843 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.

  PMID: 30137250 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.

  PMID: 22661489 DERIVED

Related Links

• Click here for more information about the ACTG A5175 study

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2004
• First Posted: November 16, 2004
• Study Start: February 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

ZI (1); BR (2); ZA (2); MA (2); IN (4)