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NCT00001899 · ClinicalTrials.gov registry record
Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy
A clinical trial of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 38
- Enrollment target
- 1
- Study location
NCT00001899: Completed study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001899 is a study of HIV Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 38 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001899, a study of HIV Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effects of increases in HIV blood levels on the immune system. A better understanding of how HIV alters the immune response may lead to development of effective immune-based therapies against the virus. Patients 18 years of age or older with HIV-1 infection who have been receiving highly active antiretroviral therapy (HAART) may be eligible for this study. In order to study the effect of increased levels of virus on the immune system, therapy will be stopped in these patients temporarily. Therefore, only patients who have an appropriate level of understanding of the potential benefits of therapy and the risks of stopping treatment will be considered for enrollment. Pregnant women may not participate and women of childbearing potential must agree not to become pregnant during the study. Candidates will be screened with a medical history, physical exam, blood and urine tests and possibly a chest X-ray and electrocardiogram. Upon entering the study, participants will have blood tests to measure the amount of virus in the blood, CD4+ T cell counts, side effects of the medications, and how the patient s immune system responds to HIV in the test tube. White cells will be collected through leukapheresis. In this procedure, a needle is placed in an arm vein and blood flows from the vein through a tube (catheter) into a cell separator machine, where the white cells are separated from the rest of the blood by a spinning process. Some of the white cells are collected by the machine, and the rest of the blood is returned to the body through a second needle placed in the other arm. Patients will then have a physical examination and blood tests every 1 to 2 weeks and will be managed according to their viral load and CD4 cell counts as follows: Viral Load * If viral blood levels remain less than 5000 copies per milliliter, no medical intervention is planned. * If viral blood levels rise to 5,000 copies per ml or higher, patients will undergo a secon
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 1998-12-16 |
| Est. Completion | 2013-04-08 |
What the finished NCT00001899 record still lists
NCT00001899 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (84% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 0 interventions.
NCT00001899 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001899 about?
NCT00001899 is a clinical study titled "Immune and Viral Status of HIV-Infected Patients After Stopping Combination Antiretroviral Therapy". This study will examine the effects of increases in HIV blood levels on the immune system. A better understanding of how HIV alters the immune response may lead to development of effective immune-based therapies against the virus. Patients 18 years of age or older with HIV-1 infection who have been...
What is the current status of trial NCT00001899?
This trial is currently completed. The enrollment target is 38 participants. The study started on 1998-12-16. Estimated completion is 2013-04-08.
What conditions does trial NCT00001899 study?
This clinical trial studies the following conditions: HIV Infection.
Who is sponsoring clinical trial NCT00001899?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001899 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00001899's enrollment target sits among peer trials
38 47th of 73 higher than 26 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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