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HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs Clinical research trials and HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs. HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs  HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
For Condition: Cognitive Disorders,HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Neurological Disorders and Stroke (NINDS),Neurologic AIDS Research Consortium (NARC)
Synopsis: 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.
Details: 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].
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 100
Location and Contact Information:
Overall Study Official:
ChristinaMarra, Study Chair, University of Washington
Miriam Hosp / Brown Univ *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting Joan Gormley 401-793-4396
Julio Arroyo *Recruiting*
West Columbia, South Carolina, 29169
United States
Recruiting Michael Klebert 314-454-0058
Univ of Hawaii *Recruiting*
Honolulu, Hawaii, 96816-2396
United States
Recruiting Debra Ogata-Arakaki 808-737-2751
San Mateo AIDS Program / Stanford Univ *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Ohio State Univ Hosp Clinic *No longer recruiting*
Columbus, Ohio, 432101228
United States
No longer recruiting
Univ of Pennsylvania at Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Christopher Helker 215-349-8092
San Francisco Gen Hosp *Recruiting*
San Francisco, California, 941102859
United States
Recruiting Marc Gould 415-476-9296
Univ of Pittsburgh *No longer recruiting*
Pittsburgh, Pennsylvania, 15213
United States
No longer recruiting
Comprehensive Care Clinic *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Janet Nicotera 615-467-0154
Columbia Presbyterian Med Ctr *No longer recruiting*
New York City, New York, 10032
United States
No longer recruiting
Univ of California / San Diego Treatment Ctr *Recruiting*
San Diego, California, 921036325
United States
Recruiting Jill Kunkel 619-543-8080
Johns Hopkins Hosp *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Rebecca Becker 410-955-4370
Univ of Washington *Recruiting*
Seattle, Washington, 98104
United States
Recruiting Jeanne Conley 206-731-8877
Univ of Puerto Rico *Recruiting*
San Juan, , 009365067
Puerto Rico
Recruiting Virginia Ramirez 787-767-9192
Univ of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Carol Greisberger 716-275-5871
Bellevue Hosp / New York Univ Med Ctr *Recruiting*
New York City, New York, 10016
United States
Recruiting Maura Laverty 212-263-6565
Univ of Cincinnati *No longer recruiting*
Cincinnati, Ohio, 452670405
United States
No longer recruiting
Willow Clinic *No longer recruiting*
Menlo Park, California, 94025
United States
No longer recruiting
Stanford Univ Med Ctr *No longer recruiting*
Stanford, California, 943055107
United States
No longer recruiting
Northwestern Univ Med School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Baiba Berzins 312-695-5012
MetroHealth Med Ctr *No longer recruiting*
Cleveland, Ohio, 441091998
United States
No longer recruiting
Univ of Texas, Southwestern Med Ctr of Dallas *No longer recruiting*
Dallas, Texas, 75390
United States
No longer recruiting
Univ of Colorado Health Sciences Ctr *Recruiting*
Denver, Colorado, 80262
United States
Recruiting M Ray 303-372-5535
Mount Sinai Med Ctr *No longer recruiting*
New York City, New York, 10029
United States
No longer recruiting
Case Western Reserve Univ *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Michael Chance 216-844-8051
Beth Israel Med Ctr *Recruiting*
New York City, New York, 10003
United States
Recruiting Ann Marshak 212-420-4432
Additional Information:
Study ID Numbers: ACTG 736; AACTG 736
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001103
Other Cognitive Disorders Studies:
1. A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients with Dementia
2. Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
3. A Study of Decreased Mental Function Associated with HIV
4. HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
Related Studies:
Other Cognitive Disorders Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
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