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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Enrollment
- 860
- Locations
- 11
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Not specified