Search / Trial NCT00001681

A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Cytokines Gene Regulation Immunization Influenza Pathogenesis

Description

The factors that influence HIV disease progression are not well understood. While larger amounts of circulating virus (high 'viral loads') predict future adverse clinical events, many of the clinical factors responsible for high viral loads and disease progression remain unknown. Certain clinical events and defined interventions are associated with increases in plasma viral RNA concentrations. One of these clinical interventions is immunization; immunization with several vaccines have been shown to increase plasma HIV RNA concentrations. Even though vaccination can lead to transient increas...

Gender

All

Eligibility criteria

  • PATIENT VOLUNTEERS:
  • HIV positive.
  • CD4 cells greater than 200, obtained within the prior 2 months.
  • Age greater than 18 years.
  • Willing and able to participate in study.
  • No immunomodulatory therapy, including other vaccinations within the prior 4 weeks. Stable therapy on G-CSF and/or thalidomide permitted.
  • No contraindications for influenza vaccination.
  • No clinical conditions that would place the patient at undo risk from the mandated protocol blood draws.
  • No recent (less than 4 weeks) changes in antiviral therapy or change in antiviral therapy anticipated during the 3 week duration of the study.
  • No history of recent (less than 4 weeks) or intercurrent blood transfusion or cytotoxic chemotherapy.
  • Hemoglobin greater than 9.0 g/dl.
  • Total volume of blood otherwise drawn should not exceed 500 ml over 6 weeks.
  • No upper respiratory infections or other acute illnesses within the prior 2 weeks.
  • CONTROL NORMAL VOLUNTEERS:
  • Age greater than 18 years.
  • Willing and able to participate in study.
  • Healthy.
  • No ongoing condition or recent (less than 4 weeks) illness requiring a physician's care.
  • No upper respiratory infections or other acute illnesses within the prior 2 weeks.
  • Total volume of blood drawn should not exceed 500 ml over 6 weeks.
  • Not taking any prescription medications.

Attachments

readout_NCT00001681_2024-05-23.pdf

4.5 MB

NCT00001681_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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