HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs

Completed

Conditions studied: Cognitive Disorders, HIV Infections

In brief

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.

Key facts

Study ID

NCT00001103

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

100

Last updated by the study team

2008-07-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Willow Clinic — Menlo Park, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• San Mateo AIDS Program / Stanford Univ — Stanford, California, United States
• Stanford Univ Med Ctr — Stanford, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Beth Israel Med Ctr — New York, New York, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Mount Sinai Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve Univ — Cleveland, Ohio, United States
• MetroHealth Med Ctr — Cleveland, Ohio, United States
• Ohio State Univ Hosp Clinic — Columbus, Ohio, United States
• Univ of Pennsylvania at Philadelphia — Philadelphia, Pennsylvania, United States
• Univ of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Miriam Hosp / Brown Univ — Providence, Rhode Island, United States
• Julio Arroyo — West Columbia, South Carolina, United States
• Comprehensive Care Clinic — Nashville, Tennessee, United States
• Univ of Texas, Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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