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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00096824
First received: November 15, 2004
Last updated: September 15, 2010
Last verified: September 2010

November 15, 2004
September 15, 2010
February 2006
May 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00096824 on ClinicalTrials.gov Archive Site
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A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175
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)

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All participants who enrolled in ACTG study 5175

HIV Infections
Behavioral: Neurological assessment
All participants will undergo neurological examinations and neuropsychological assessments.
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.
Intervention: Behavioral: Neurological assessment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
960
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   India,   Malawi,   South Africa,   Zimbabwe
 
NCT00096824
ACTG A5199, 1U01AI068636
Yes
Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
Study Chair: 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
AIDS Clinical Trials Group
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP