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Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients Clinical research trials and Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients. Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients clinical trial. Human subjects often obtain the finest healthcare possible for their Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients  Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients
Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients
For Condition: HIV Infection,Immunologic Deficiency Syndrome
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will examine how quickly white blood cells called CD4 lymphocytes replicate (divide) and how long they live in both HIV-infected and non-infected people by measuring how quickly the genetic material (DNA) of cells is replicated. To do this, participants will receive infusions of glucose, a non-radioactive form of a type of sugar. Cells normally use glucose to make various products needed for cell growth and replication, including cell DNA. Measuring how much glucose cells incorporate into their DNA can provide important information about cell replication. This rate of incorporation will be examined and compared in HIV-infected people and in healthy, normal volunteers. HIV-infected patients and non-infected healthy volunteers 18 years of age and older may be eligible for this study. Candidates will be screened with a medical history, physical examination, chest X-ray, electrocardiogram (EKG) and blood tests. Participants will be given a continuous infusion of glucose at a dose of up to 60 grams (about 2 ounces) per day for up to 5 days. The glucose will be delivered through a catheter (thin plastic tube) placed in an arm vein. Blood samples will be collected as often as daily in the first week following the infusion and then from twice a week to once a month for up to 4 years. Alternatively, patients may undergo leukapheresis-a procedure for collecting quantities of lymphocytes-up to 10 times during the first month after the infusion, and possibly later as well, but no more often than once every 2 weeks. For this procedure, whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body either through the same needle or through a second needle in the other arm. Participants may be asked to receive up to four glucose infusions. There will be at least a 2-week interval between infusions. Participants who have more than three leukapheresis procedures within 3 weeks will have at least 6 weeks between infusions. Participants will be followed periodically in the outpatient clinic for evaluation and tests. This study may provide a better understanding of how HIV causes disease and progressive weakening of the immune system and how therapies affect immunity.
Details: Understanding the rate of lymphocyte replication and destruction in HIV-infected patients, as well as the effects of therapy on lymphocyte replication should lead to a better understanding of the mechanisms behind the immunodeficiency induced by HIV. To examine this directly, up to 100 HIV-infected patients will receive up to 5 days of continuous infusions with [6,6-2H2]-glucose, a nonradioactive, stable isotope of glucose that is safe to administer. The deuterium is incorporated into DNA via metabolism of glucose to ribose and incorporation into nucleotides. The rate of incorporation can be measured in subpopulations of cells to determine the rate of replication of those cells. Fifty HIV-uninfected persons will also be enrolled in the protocol to allow a determination of lymphocyte kinetics in individuals with normally functioning immune systems or immune systems that may have been affected by other diseases. All participants in this study will be reimbursed for the inconvenience and discomfort associated with study participation.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: FOR PATIENTS: 18 years or older Able to provide informed consent and willing to comply with study requirements and clinic policies Negative urine pregnancy test (for women of childbearing potential) Hemoglobin greater than 10 mg/dl Adequate venous access in the arms for blood drawing and 5 day infusions FOR HIV POSITIVE PATIENTS: Documented HIV infection (ELISA/Western blot positive or, for acute seroconverters, PCR positive) FOR HIV NEGATIVE PATIENTS: Negative ELISA/Western blot. EXCLUSION CRITERIA: Diabetes mellitus requiring drug therapy Active substance abuse or prior history of substance abuse which may interfere with protocol compliance Psychiatric illness or disturbance which, in the assessment of the protocol team, may affect patient safety or compliance Significant underlying cardiac, pulmonary, renal, gastrointestinal, rheumatologic or CNS disease as detectable on routine history, physical exam, or screening laboratory studies. Patients would be excluded if they had an acute or chronic underlying medical problem that in the judgement of the principal investigator could be exacerbated by participating in the protocol or that would make it difficult for them to comply with the protocol requirements. Pregnancy or breast-feeding
Total Enrollment: 150
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 970191; 97-I-0191
Study Start Date: September 18, 1997
Record last reviewed: August 7, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001651
Other Immunologic Deficiency Syndrome Studies:
1. Drug Interactions Among Anti-HIV Agents
2. Analysis of HIV Genetic Variation in Patients Before Beginning Highly Active Antiretroviral Therapy
3. Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients
4. A Phase I/II Study of the Combination of Azidothymidine and Interleukin-2 (IL-2) in the Treatment of HIV-Infected Patients
5. Evaluation of the Significance of Anti-HIV Antibody in Asymptomatic Blood Donors
Related Studies:
Other Immunologic Deficiency Syndrome Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Use of Labeled Glucose to Study Lymphocyte Replication and Survival in HIV-Infected Patients
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