A Study of Dementia and Neurological Problems in HIV Infected Patients Who Are Participating in ACTG A5175
- Conditions
- HIV Infections
- Interventions
- Behavioral: Neurological assessment
- Registration Number
- NCT00096824
- Lead Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 860
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Neurological assessment 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.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
YRG Center for AIDS Research and Education
🇮🇳Chennai, India
National Institute of Virology (NARI)
🇮🇳Pune, India
University of Zimbabwe
🇿🇼Harare, Zimbabwe
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, RS, Brazil
Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz
🇧🇷Rio de Janeiro, Brazil
Dr. Kotnis Dispensary
🇮🇳Pune, India
National AIDS Research Institute (NARI) ICMR
🇮🇳Pune, India
University of KwaZulu Natal
🇿🇦Durban, KZN, South Africa
University of Witwatersrand
🇿🇦Johannesburg, South Africa
The Johns Hopkins-Malawi College of Medicine Project
🇲🇼Blantyre, Malawi
University of North Carolina Project (UNC Project)
🇲🇼Lilongwe, Malawi