Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||November 20, 2014|
|Start Date ICMJE||May 1991|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The purpose of this protocol is to provide a mechanism to obtain blood products and otherbiologic samples that will be used by NIH Intramural Investigators in studies of HIV andrelated diseases. In addition to obtaining plasma, serum and w... [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001281 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Studies of Blood and Reproductive Fluids in HIV-Infected and Non-HIV-Infected Persons|
|Official Title ICMJE||Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Reproductive Fluids in HIV-Infected and HIV-Uninfected Volunteers|
This study will examine the effects of HIV infection on substances produced by immune cells that increase or decrease HIV infection.
HIV-infected patients and healthy normal volunteers may be eligible for this study. Participants will be required to have a yearly medical evaluation, including blood tests for cell counts and chemistries, a blood or urine pregnancy test for women, and other laboratory tests as medically indicated or for research purposes.
Participants will donate blood or reproductive fluids, or both. From 20 to 150 cc (4 to 30 teaspoonfuls) of blood will be drawn from the arm using a small needle. Participants may be asked to provide blood samples on more than one occasion over the course of the study. No more than 450 cc (less than 1 pint) of blood will be drawn during any 6-week period. Males will be given a private room for semen donation; fluid from females will be collected with a cotton swab after speculum insertion. Participants may also be asked to have a buccal swab. For this procedure, the inside of the cheek is gently scraped with a blunt-ended stick or brush to obtain cells (buccal mucosal cells). The tissues will be used for a variety of studies on the effects of HIV infection on factors that increase or decrease HIV infection.
Some of the tissues collected for this study may also be used for the following tests:
We are studying the pathogenesis of HIV infection. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection using human peripheral blood mononuclear cells as a model.
|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||HIV Infection|
|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||1800|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Adequate venous access.
Have a blood pressure less than or equal to 180/100: pulse rate 50-100, unless a lower pulse rate is considered normal for the volunteer.
Have adequate blood counts (HIV positive volunteers: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 38%, platelets greater than or equal to 150,000)
Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening.
Pregnant and/or breastfeeding females.
Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001281|
|Other Study ID Numbers ICMJE||910140, 91-I-0140|
|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||Washington Hospital Center|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP