Completed
Cerebrospinal Fluid Human Immunodeficiency Virus-1 (HIV-1) and Cognitive Function in Individuals Receiving Potent Antiretroviral Therapy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-07-29
100
Participants Needed
26
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HIV Levels in Cerebrospinal Fluid and Brain Function in Patients Receiving Anti-HIV Drugs
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 26 locations
1
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
2
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
3
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
4
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
5
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
6
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
7
Univ of Hawaii
Honolulu, Hawaii, United States, 96816-2396
Status Unknown
8
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
9
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
10
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
11
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
12
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
13
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
14
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
15
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
16
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
17
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Status Unknown
18
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
19
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
20
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Status Unknown
21
Miriam Hosp / Brown Univ
Providence, Rhode Island, United States, 02906
Status Unknown
22
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
23
Comprehensive Care Clinic
Nashville, Tennessee, United States, 37203
Status Unknown
24
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75390
Status Unknown
25
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
26
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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