Clinical Trials


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

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
Last updated: July 28, 2008
Last Verified: May 2006
History of Changes


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.

Cognitive Disorders
HIV Infections

Study Type: Observational
Official Title: Cerebrospinal Fluid Human Immunodeficiency Virus-1 (HIV-1) and Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Enrollment: 100

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 neuropsychological tests. While combination antiretroviral treatments are potent suppressors of HIV-1 replication in plasma, the extent to which these treatments suppress viral replication in CSF is unknown. A few studies suggest that antiretroviral treatments can reduce HIV-1 RNA in CSF. However, since CSF is isolated from peripheral immune responses to HIV and antiretroviral treatment may not readily penetrate the compartment, researchers hypothesize the remaining virus will overcome the antiretroviral treatment to achieve high levels of viral replication again. This virologic failure is likely accompanied by decreased cognitive function. It is therefore critical to determine the ability of antiretroviral treatments to control HIV-1 replication in the CSF and the durability of that viral suppression.
Patients enrolling in one of several AACTG-sponsored potent antiretroviral therapy trials (a "parent" trial) may enter this study. [AS PER AMENDMENT 06/06/00: Patients already enrolled in an AACTG-sponsored study who are changing treatment due to virologic failure may also enter this study.] [AS PER AMENDMENT 11/15/01: Patients starting a new potent antiretroviral regimen as part of their clinical care, enrolling in a potent antiretroviral treatment trial, or changing potent antiretroviral therapy in clinical care or in an ongoing antiretroviral treatment trial because of virologic failure may enter this study.] Patients receive no treatment but undergo various procedures aimed at characterizing the effects of antiretroviral therapies on CSF viral load and cognitive function. Procedures include: 1) venipuncture to measure plasma HIV-1 RNA and DNA levels, CD4+ T cell count, and cytokine and immune activation markers associated with HIV-1 neurological disorders; 2) neuropsychological examinations to measure cognitive function; and 3) lumbar punctures to obtain CSF samples, which are used to determine the pharmacokinetics of antiretroviral agents in CSF and to determine levels of blood cells, cytokine and immune activation markers, and HIV-1 RNA and DNA. An entry visit must occur before initiating potent antiretroviral therapy in the parent trial [AS PER AMENDMENT 06/06/00: or before changing the antiretroviral regimen due to virologic failure in an ongoing trial]. [AS PER AMENDMENT 11/15/01: Patients are registered before initiating a new potent antiretroviral regimen.] Subsequent visits occur within 21 days prior to each lumbar puncture and at Weeks 24 and 52. If evaluations, procedures, or assays for a given patient's parent trial [AS PER AMENDMENT 11/15/01: for any coenrollment AACTG study] occur at the times specified in this study, they are not duplicated for this study. Other visits may occur when a patient changes antiretroviral treatment or discontinues a parent trial [AS PER AMENDMENT 11/15/01: discontinues a potent antiretroviral therapy].



Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00001103


United States, California
Willow Clinic
Menlo Park, California, United States, 94025
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
United States, Colorado
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
United States, Hawaii
Univ of Hawaii
HonolulU, Hawaii, United States, 96816-2396
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Mount Sinai Med Ctr
New York, New York, United States, 10029
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States, 02906
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Comprehensive Care Clinic
Nashville, Tennessee, United States, 37203
United States, Texas
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75390
United States, Washington
Univ of Washington
Seattle, Washington, United States, 98104
Puerto Rico
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Neurological Disorders and Stroke (NINDS)
Neurologic AIDS Research Consortium (NARC)


Study Chair: Christina Marra, MD University of Washington
Study Chair: Kevin Robertson, PhD University of North Carolina, Chapel Hill
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00001103   History of Changes  
Other Study ID Numbers: ACTG 736  
  AACTG 736  
Study First Received: November 2, 1999  
Last Updated: July 28, 2008  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Neuropsychological Tests
RNA, Viral
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
Cognition Disorders processed this data on March 27, 2020
This information is provided by