Status:
COMPLETED
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)
Conditions:
Cognitive Disorders
HIV Infections
Eligibility:
All Genders
Brief Summary
The purpose of this study is to see whether anti-HIV drugs that reduce HIV in the blood also reduce HIV in the cerebrospinal fluid (CSF). CSF is the fluid found around the brain and spinal cord. This ...
Detailed Description
HIV-1 RNA emerges in CSF early in the course of HIV disease. Studies have shown that high levels of HIV-1 RNA in CSF correlate with increased severity of dementia and worsened performance on neuropsyc...
Eligibility Criteria
Inclusion Criteria
- Are HIV-positive.
- Have levels of CD4 cells (immune cells that fight infection) less than 200 cells/mm3 and viral loads (level of HIV in the blood) greater than 2,000 copies/ml or viral loads greater than 50,000 copies/ml and any CD4 cell levels.
- Are either: 1) starting a new potent antiretroviral therapy for HIV; 2) enrolling in a potent antiretroviral trial; or 3) currently participating in an ongoing antiretroviral trial or in clinical care and will be changing treatment due to treatment failure. The entry visit for ACTG 736 must occur before starting the treatment or before changing to the new treatment. (This study has been changed to include patients who have changed treatment due to treatment failure and those who are starting a new anti-HIV regimen.)
Exclusion Criteria
- Have an infection or cancer in the brain or certain diseases of the brain or nervous system.
- Have a serious psychiatric illness (such as schizophrenia or severe depression).
- Have completed treatment for a significant infection within 4 weeks of beginning the study (but certain drugs that fight infection are allowed on this study).
- Are taking drugs to prevent or dissolve blood clots.
- Abuse drugs or alcohol.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00001103
Last Update
July 29 2008
Active Locations (26)
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1
Willow Clinic
Menlo Park, California, United States, 94025
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
3
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
4
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107