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

March 17, 2015 updated by: AIDS Clinical Trials Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

860

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All participants who enrolled in ACTG study 5175

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIDS Clinical Trials Group

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 15, 2004

First Submitted That Met QC Criteria

November 15, 2004

First Posted (Estimate)

November 16, 2004

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5199
  • 1U01AI068636 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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