Studies of Lymphocyte Kinetics Using Stable Isotopes
[6,6-2H2]-glucose
+ [6,6-2H2]-glucose
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Basic Science Study
Summary
Study start date: February 25, 1998
Actual date on which the first participant was enrolled.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-(2)H(2)]-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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.54 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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, and lymphapheresis Willingness to allow stored samples to be used for future studies of HIV infection and/or immunological function, and willingness to have HLA typing performed. (For previously enrolled patients, patients would be requested, but not required, to provide permission to use stored samples in the future, and to permit HLA testing 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 judgment 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps