Status:
COMPLETED
A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
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% ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
860 Patients enrolled
Trial Details
Trial ID
NCT00096824
Start Date
February 1 2006
End Date
May 1 2010
Last Update
March 18 2015
Active Locations (11)
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1
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
2
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
Rio de Janeiro, Brazil, 21045-900
3
YRG Center for AIDS Research and Education
Chennai, India, 60001-7
4
Dr. Kotnis Dispensary
Pune, India, 411026