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
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.
연구 개요
상세 설명
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].
연구 유형
등록
연락처 및 위치
연구 장소
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California
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Menlo Park, California, 미국, 94025
- Willow Clinic
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San Diego, California, 미국, 921036325
- Univ of California / San Diego Treatment Ctr
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San Francisco, California, 미국, 941102859
- San Francisco Gen Hosp
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Stanford, California, 미국, 943055107
- San Mateo AIDS Program / Stanford Univ
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Stanford, California, 미국, 943055107
- Stanford Univ Med Ctr
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Colorado
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Denver, Colorado, 미국, 80262
- Univ of Colorado Health Sciences Ctr
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Hawaii
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HonolulU, Hawaii, 미국, 96816-2396
- Univ of Hawaii
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern Univ Med School
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Hosp
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New York
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New York, New York, 미국, 10003
- Beth Israel Med Ctr
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New York, New York, 미국, 10016
- Bellevue Hosp / New York Univ Med Ctr
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New York, New York, 미국, 10029
- Mount Sinai Med Ctr
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New York, New York, 미국, 10032
- Columbia Presbyterian Med Ctr
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Rochester, New York, 미국, 14642
- Univ of Rochester Medical Center
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Ohio
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Cincinnati, Ohio, 미국, 452670405
- Univ of Cincinnati
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Cleveland, Ohio, 미국, 44106
- Case Western Reserve Univ
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Cleveland, Ohio, 미국, 441091998
- MetroHealth Med Ctr
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Columbus, Ohio, 미국, 432101228
- Ohio State Univ Hosp Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- Univ of Pennsylvania at Philadelphia
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Pittsburgh, Pennsylvania, 미국, 15213
- Univ of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- Miriam Hosp / Brown Univ
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South Carolina
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West Columbia, South Carolina, 미국, 29169
- Julio Arroyo
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Tennessee
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Nashville, Tennessee, 미국, 37203
- Comprehensive Care Clinic
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Texas
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Dallas, Texas, 미국, 75390
- Univ of Texas, Southwestern Med Ctr of Dallas
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Washington
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Seattle, Washington, 미국, 98104
- Univ of Washington
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San Juan, 푸에르토 리코, 009365067
- Univ of Puerto Rico
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Christina Marra, MD, University of Washington
- 연구 의자: Kevin Robertson, PhD, University of North Carolina, Chapel Hill
연구 기록 날짜
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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