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

Conditions

HIV Infections

Keywords

Acute Infection, Treatment Naive

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.

Detailed description

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.

Michael HU, Rapulana AM, Smit T, Xulu N, Danaviah S, Ramlall S, Oosthuizen F.

2025-05-03

10.1038/s41598-025-99569-6

Human Immunodeficiency Virus-associated Neurocognitive Impairment in Diverse Resource-limited Settings

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Clinical Infectious Diseases2018-09-1218 citations

10.1093/cid/ciy767

Human Immunodeficiency Virus Type 1 and Tuberculosis Coinfection in Multinational, Resource-limited Settings: Increased Neurological Dysfunction

Kevin R. Robertson, Bibilola Oladeji, Hongyu Jiang, Johnstone Kumwenda, Khuanchai Supparatpinyo et al. (30 authors)

Clinical Infectious Diseases2018-08-1718 citations

10.1093/cid/ciy718

Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group study a5199, the International Neurological Study.

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.

2012-06-0152 citations

10.1093/cid/cis507

Interventions

BEHAVIORALNeurological assessment

All participants will undergo neurological examinations and neuropsychological assessments.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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

Exclusion criteria

* 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

Countries

Brazil, India, Malawi, South Africa, Zimbabwe

Outcome results

None listed