A Pilot Study of the Patterns of Cellular Gene Expression in HIV-1 Patients Following Clinical Events Which Increase Plasma Virus Concentrations
Public ClinicalTrials.gov record NCT00001681. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 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.
Study identification
- NCT ID
- NCT00001681
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 1997
- Primary completion
- Not listed
- Completion
- Aug 31, 2000
- Last update posted
- Mar 3, 2008
1997 – 2000
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Cancer Institute (NCI) | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00001681, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 3, 2008 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001681 live on ClinicalTrials.gov.