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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:
AIDS Clinical Trials Group
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00096824
First received: November 15, 2004
Last updated: March 17, 2015
Last verified: March 2015
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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:
| Enrollment: | 860 |
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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
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 |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AIDS Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00096824 History of Changes |
| Other Study ID Numbers: |
ACTG A5199 1U01AI068636 ( U.S. NIH Grant/Contract ) |
| Study First Received: | November 15, 2004 |
| Last Updated: | March 17, 2015 |
Keywords provided by AIDS Clinical Trials Group:
|
Acute Infection Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on August 18, 2017