HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
Cerebrospinal Fluid Human Immunodeficiency Virus-1 (HIV-1) and Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy
2 other identifiers
observational
100
2 countries
26
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 study also looks at whether reducing HIV in the CSF can help protect brain function. HIV can be detected in the brain and CSF early in HIV disease. Anti-HIV drugs probably reduce HIV in the CSF. This may be important because other studies have suggested high CSF HIV levels may lead to some loss of brain function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJuly 29, 2008
May 1, 2006
November 2, 1999
July 28, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Hawaii
Honolulu, Hawaii, 96816-2396, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Columbia Presbyterian Med Ctr
New York, New York, 10032, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
MetroHealth Med Ctr
Cleveland, Ohio, 441091998, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Comprehensive Care Clinic
Nashville, Tennessee, 37203, United States
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390, United States
Univ of Washington
Seattle, Washington, 98104, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christina Marra, MD
University of Washington
- STUDY CHAIR
Kevin Robertson, PhD
University of North Carolina, Chapel Hill