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
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Neurological assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Estimated Enrollment: 960
Study Start Date: February 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
All participants will undergo neurological examinations and neuropsychological assessments.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All participants who enrolled in ACTG study 5175

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096824

Locations
Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS, Brazil, 91350-200
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
Rio de Janeiro, Brazil, 21045-900
India
YRG Center for AIDS Research and Education
Chennai, India, 60001-7
Dr. Kotnis Dispensary
Pune, India, 411026
National AIDS Research Institute (NARI) ICMR
Pune, India, 411026
National Institute of Virology (NARI)
Pune, India, 411026
Malawi
The Johns Hopkins-Malawi College of Medicine Project
Blantyre, Malawi
University of North Carolina Project (UNC Project)
Lilongwe, Malawi
South Africa
University of KwaZulu Natal
Durban, KZN, South Africa, 4013
University of Witwatersrand
Johannesburg, South Africa
Zimbabwe
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
ClinicalTrials.gov Identifier: NCT00096824     History of Changes
Other Study ID Numbers: ACTG A5199, 1U01AI068636
Study First Received: November 15, 2004
Last Updated: September 15, 2010
Health Authority: United States: Federal Government

Keywords provided by AIDS Clinical Trials Group:
Acute Infection
Treatment Naive

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Reverse Transcriptase Inhibitors
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014