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


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N/A
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

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


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 increases in plasma HIV
concentrations, certain vaccines, including influenza vaccine, are still recommended for HIV
patients because the risks of the disease targeted by the immunization are held to be
greater than the immunization itself. Therefore, immunization with influenza vaccine can be
considered a model, clinically indicated intervention, given at a known time which
stimulates HIV replication. For influenza immunization, and for other treatments leading to
increases in viral RNA concentrations, detailed knowledge of the regulatory events that
mediate the increase in RNA concentrations is not available. We hypothesize that
immunization with influenza vaccine, and perhaps other immune stimulatory events, lead to an
increase in HIV replication through a regulatory system involving cytokines, signal
transduction systems, transcription factors, effects on the cell cycle, and increased
expression of additional gene products needed for viral replication, such as genes of the
nucleic acid biosynthetic pathways. While experiments aimed at investigating one or another
particular part of this regulatory system can be performed with traditionally available
technologies, such technologies cannot provide comprehensive information concerning a large
number of the regulatory events that may be involved in mediating the increase in HIV RNA
concentration. In this protocol, we aim to develop the methodologies needed to determine
changes in expression of many of the genes which may be involved in mediating the regulation
of HIV expression in HIV-infected patients using cDNA microarray technologies. Once the
methodologies are developed, such work may provide new insights into the regulatory systems
controlling HIV expression in HIV-infected patients may provide new insights into the
pathogenesis of HIV disease.

Inclusion 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.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

980011

NCT ID:

NCT00001681

Start Date:

October 1997

Completion Date:

September 2000

Related Keywords:

  • HIV Infections
  • Cytokines
  • Gene Regulation
  • Immunization
  • Influenza
  • Pathogenesis
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892