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NCT00286767 · ClinicalTrials.gov registry record
Immune Reconstitution Syndrome in HIV-Infected Patients Taking Antiretroviral Therapy
A clinical trial of Immune Reconstitution Inflammatory Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 525
- Enrollment target
- 3
- Study locations
NCT00286767: Completed study of Immune Reconstitution Inflammatory Syndrome, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00286767 is a study of Immune Reconstitution Inflammatory Syndrome that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 525 participants. The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00286767, a study of Immune Reconstitution Inflammatory Syndrome, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 525 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. IRIS is a condition that can occur in HIV-infected people following the start of antiretroviral therapy. The sudden improvement of immune function with this therapy can cause an unexpected worsening of diseases the patient already has, such as tuberculosis or fungal infections, and development of fever, enlarged lymph nodes or other complications, or even uncover a previously silent disease. HIV-infected people who are at least 18 years old, whose CD4+T cell count is 100 cells per microliter or less, and who have not previously been treated with combination antiretroviral therapy or have taken the drugs for less than 3 months and more than 6 months before screening for this study may be eligible to participate. Candindates must also live within the wider DC area so that acute problems after therapy initiation will be evaluated at NIH. Candidates are evaluated before starting therapy with a medical history and physical examination, blood and urine tests, electrocardiogram, chest x-ray and CT scan of the chest, tuberculin skin testing, apheresis, and possibly an intestinal (gut) and lymph node biopsy (surgical removal of a small piece of tissue for microscopic examination). For apheresis, blood is collected through a needle in an arm vein and spun in a machine that separates the blood components. The white blood cells and plasma are removed, and the red cells and platelets are returned through the same needle or through a needle in a vein in the other arm. Participants have a complete history and physical examination and additional blood tests, including genetic studies, upon entering the study. They start taking anti-HIV medications, prescribed according to the current standard of care, as well as medications to treat other infections,
Conditions Studied
Study Locations (3)
Other
- The Thai Red Cross AID Research Center (TRC-ARC) - Bangkok
- Bamrasnaradura Infectious Disease Institute (BIDI) - Nonthaburi
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2006-02-01 |
| Est. Completion | 2018-11-01 |
What the finished NCT00286767 record still lists
NCT00286767 is an observational study that tracks outcomes without assigning an intervention. The registered 525 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Immune Reconstitution Inflammatory Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT00286767 reports a single indexed study location in Other, Maryland.
Frequently Asked Questions
What is clinical trial NCT00286767 about?
NCT00286767 is a clinical study titled "Immune Reconstitution Syndrome in HIV-Infected Patients Taking Antiretroviral Therapy". This study will investigate what factors may lead to the development of immune reconstitution syndrome (IRIS) in HIV-infected patients and what the outcome is after IRIS. It will also seek to better define and describe the syndrome. IRIS is a condition that can occur in HIV-infected people following...
What is the current status of trial NCT00286767?
This trial is currently completed. The enrollment target is 525 participants. The study started on 2006-02-01. Estimated completion is 2018-11-01.
What conditions does trial NCT00286767 study?
This clinical trial studies the following conditions: Immune Reconstitution Inflammatory Syndrome.
Who is sponsoring clinical trial NCT00286767?
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 NCT00286767 being conducted?
This trial has 3 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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