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NCT00091884 · ClinicalTrials.gov registry record
Efficacy of Elevated CD4 Counts on CMV Retinitis
A clinical trial of Acquired Immunodeficiency Syndrome and Cytomegalovirus Retinitis, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- 15
- Enrollment target
- 1
- Study location
NCT00091884: Completed study of Acquired Immunodeficiency Syndrome and Cytomegalovirus Retinitis, sponsored by National Eye Institute (NEI).
NCT00091884 is a study of Acquired Immunodeficiency Syndrome and Cytomegalovirus Retinitis that has completed, run by National Eye Institute (NEI). The registered enrollment target is 15 participants, below the 216-participant average among 17 other Acquired Immunodeficiency Syndrome trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00091884, a study of Acquired Immunodeficiency Syndrome and Cytomegalovirus Retinitis, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV all have serious side effects. AIDS patients are prone to this infection because their immune system produces a lower number of CD4+T lymphocytes, the type of blood cells that fight viral infections. Some new HIV medications strengthen the immune system. This study will investigate the possibility that CMV patients on these HIV medications can develop immune systems strong enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have inactive CMV retinitis that is not immediately sight threatening. It is expected to last approximately 2 years. Each prospective participant will have a physical examination and complete eye examination, including retina photographs, with the eye examination and retina photographs repeated 2 weeks later. If there is no evidence of active CMV retinitis, the participant will be enrolled in the study, and CMV medication will be stopped. The participant will have physical and eye examinations every 2 weeks for the first 3 months of the study, and every 3 weeks for the next 3 months. After 6 months, the frequency of the examinations will be 2-8 weeks, depending on the participant's CD4 count. After one year, a participant with a CD4 count remaining over 150 cells/microliter may return to the care of a local ophthalmologist with HIV/CMV experience, revisiting the clinical center every 6 months. The participant's CMV medication will be restarted when CMV retinitis becomes active, which will terminate participation in the study.
Conditions Studied
Study Locations (1)
Maryland
- National Eye Institute (NEI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-07 |
| Est. Completion | 2005-04 |
What the finished NCT00091884 record still lists
NCT00091884 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 216-participant average among 17 other Acquired Immunodeficiency Syndrome trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Acquired Immunodeficiency Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT00091884 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00091884 about?
NCT00091884 is a clinical study titled "Efficacy of Elevated CD4 Counts on CMV Retinitis". Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV all have serious side effects. AIDS patients are prone to this infection because their immune system produces a low...
What is the current status of trial NCT00091884?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2004-07. Estimated completion is 2005-04.
What conditions does trial NCT00091884 study?
This clinical trial studies the following conditions: Acquired Immunodeficiency Syndrome, Cytomegalovirus Retinitis.
Who is sponsoring clinical trial NCT00091884?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00091884 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00091884's enrollment target sits among peer trials
15 16th of 17 higher than 1 of 17 other Acquired Immunodeficiency Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acquired Immunodeficiency Syndrome 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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