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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096824
• Other study ID #: ACTG A5199
• Secondary ID: 1U01AI068636
• Status: Completed
• Phase: N/A
• First received: November 15, 2004
• Last updated: March 17, 2015
• Start date: February 2006
• Est. completion date: May 2010

Study information

• Verified date: March 2015
• Source: AIDS Clinical Trials Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Neurological assessment
All participants will undergo neurological examinations and neuropsychological assessments.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Clinical Trials Group	National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

Brazil,  India,  Malawi,  South Africa,  Zimbabwe, 

References & Publications (4)

Albright AV, Soldan SS, González-Scarano F. Pathogenesis of human immunodeficiency virus-induced neurological disease. J Neurovirol. 2003 Apr;9(2):222-7. Review. — View Citation

McArthur JC, Haughey N, Gartner S, Conant K, Pardo C, Nath A, Sacktor N. Human immunodeficiency virus-associated dementia: an evolving disease. J Neurovirol. 2003 Apr;9(2):205-21. Review. — View Citation

Sacktor N, McDermott MP, Marder K, Schifitto G, Selnes OA, McArthur JC, Stern Y, Albert S, Palumbo D, Kieburtz K, De Marcaida JA, Cohen B, Epstein L. HIV-associated cognitive impairment before and after the advent of combination therapy. J Neurovirol. 2002 Apr;8(2):136-42. — View Citation

Sacktor N. The epidemiology of human immunodeficiency virus-associated neurological disease in the era of highly active antiretroviral therapy. J Neurovirol. 2002 Dec;8 Suppl 2:115-21. Review. — View Citation

External Links

•   Click here for more information about the ACTG A5175 study
•   Haga clic aquí para ver información sobre este ensayo clínico en español.