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
HIV Infections

Further Study Details: 

Expected Total Enrollment:  960

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

South Africa
      University of Witwatersrand, Johannesburg,  South Africa

Study chairs or principal investigators

Kevin Robertson, PhD,  Study Chair,  Department of Neurology, University of North Carolina at Chapel Hill   
Johnstone Kumwenda, MD, MBBS, MMED,  Study Chair,  Internal Medicine, Johns Hopkins Project   
Khuanchai Supparatpinyo, MD,  Study Chair,  Research Institute for Health Sciences, Chiang Mai University   

Study ID Numbers:  ACTG A5199
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  November 15, 2004
ClinicalTrials.gov Identifier:  NCT00096824
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08