Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096824
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2004-11-15
Brief Title:
A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PINNRTI Therapy Combinations for Treatment Naive HIV Infected Patients in Resource-limited Conditions
The study will last approximately 25 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
The study will last approximately 25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01AI068636 | NIH | None | httpsreporternihgovquickSearch1U01AI068636 |