Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
|First Received Date ICMJE||January 11, 2002|
|Last Updated Date||November 11, 2014|
|Start Date ICMJE||January 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Studies of HIV-specific immunity [ Time Frame: Ongoing ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00029445 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Cohort Natural History Study [ Time Frame: Ongoing ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors|
|Official Title ICMJE||Evaluation of Viral Factors and Immune Parameters to Study HIV-Specific Immunity|
This study will collect white blood cells and plasma for research on how the immune system controls HIV infection. The immune system of a very small group of HIV-infected patients, called non-progressors, has been able to control HIV for long periods without antiretroviral therapy. Some immune system-related genes important for this control have been identified in these patients. This study will examine the contribution of HLA genes B*57+, B*27+ and A*01+ to HIV disease in progressors and long-term non-progressors. (HLA type is a genetic marker of the immune system.)
HIV-infected patients 18 years of age and older with HLA types B*57+, B*27+ and/or A*01+ may be eligible for this study.
Participants will undergo apheresis a method for collecting larger quantities of certain blood components than can safely be collected through a simple blood draw by one of the following two methods:
Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system. Some of the blood may be used to screen for different types of viral liver infections, such as hepatitis A, B, C, D, E, F, or G.
In an attempt to elucidate the mechanism(s) of immune-mediated restriction of HIV viral replication, we aim to study four groups of individuals: 1) HIV-infected long-term nonprogressors (LTNP), who appear to control HIV primarily through virus-specific cellular immunity; 2) HIV-infected patients who have broadly cross neutralizing antibody activity against HIV; 3) HIV-infected patients receiving antiretroviral therapy who will undergo a treatment interruption; and 4) the family members of patients exhibiting immunologic control of HIV infection. Although most of our previous efforts have focused on investigating the virus-specific immune responses in a unique group of patients termed LTNP who control HIV by cellular immune-mediated mechanisms, more recently, another group of rare individuals who naturally develop broadly cross neutralizing antibody activity against HIV isolates have also been identified in our laboratory. Passive transfer studies in nonhuman primates have demonstrated that neutralizing antibodies detectable in a subject at the time of challenge can protect from infection. We aim to recruit more of these patients in an effort to further characterize and compare their virus-specific cellular and humoral immune responses with those in individuals experiencing progressive infection. In addition, it is necessary to define whether putative correlates of immune mediated restriction of viral replication are a cause or an effect of HIV viremia. To this end, we are enrolling patients who will be discontinuing their antiretroviral regimen and examine virologic and immunologic parameters during the treatment interruption. Through this arm of the study, we will attempt to further characterize the mechanisms by which HIV evades and/or suppresses an effective anti-viral immune response and to identify features of the virus or the patients immune responses that are associated with virologic control following treatment interruption. As we attain greater insight into differences between these patient groups, we hope to perform genetic studies that would enable us to more precisely identify susceptibility or protective genes, which could be potentially used to construct a familial pedigree. We anticipate that all of these findings will contribute to an enhanced understanding of the nature of effective HIV-specific humoral and cellular immunity, which will help focus future vaccine design efforts. For our studies, it will be necessary to obtain larger quantities of plasma or mononuclear cells than can be safely obtained by simple phlebotomy. These components can be easily and safely obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is designed to conform to the requirements of the Apheresis Unit for donors to have leukapheresis or plasmaapheresis procedures.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Human Immunodeficiency Virus|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
An HIV-seropositive patient categorized as an LTNP as defined by clinical and laboratory criteria, regardless of HLA class I type.
HIV-seropositive HLA B*27+, B*35+, B*44+, B*57+, B*58+ and/or A*02+ progressors.
HIV-seropositive patients possessing sera with broadly cross-neutralizing antibody activity to HIV.
Persons who are seronegative for HIV but are family members of seropositive patients exhibiting immunologic control of HIV.
EXCLUSION CRITERIA FOR PATIENTS NOT INCLUDED UNDER THE TREATMENT INTERRUPTION ARM:
INCLUSION CRITERIA FOR PATIENTS CONSENTING TO UNDERGO A TREATMENT INTERRUPTION:
EXCLUSION CRITERIA FOR PATIENTS CONSENTING TO UNDERGO A TREATMENT INTERRUPTION:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00029445|
|Other Study ID Numbers ICMJE||020086, 02-I-0086|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP