Immune Activity Against CVM Retinitis
Public ClinicalTrials.gov record NCT00001611. 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.
Official title
Efficacy of Elevated CD4 Cell Counts on CMV Retinitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will investigate whether medication for cytomegalovirus (CMV) retinitis-a viral infection of the eye-can safely be stopped in HIV-infected patients whose immune function has improved from anti-HIV therapy. Medicines taken to fight CMV infection (ganciclovir, foscarnet, and cidofovir) can cause serious side effects, such as low blood counts and kidney damage. Stopping these medications may, therefore, be beneficial. Patients with HIV infection who develop CVM retinitis usually have very low levels of infection-fighting white blood cells called CD4 cells-less than 50 cells per microliter of blood. New anti-HIV medications have been able to raise CD4 levels and improve immune function in many patients. This study will see if patients with CD4 levels above 150 cells per microliter can fight CVM retinitis without additional anti-CVM drugs. HIV-infected patients with CVM retinitis will have a physical examination and complete eye examination. These tests will be repeated after 2 weeks. If there is no evidence that the CMV infection has progressed, and if it is in a location that is not immediately sight-threatening, anti-CMV medications will be stopped. Patients will be examined every 2 weeks for 3 months and then every 3 weeks for the next 3 months. Patients whose CD4 count has remained above 100 after 6 months will continue to be followed every 4 weeks until the CVM infection becomes active again. At that time, anti-CVM medicines will be re-started. Patients will also have blood and urine samples taken to test for levels of HIV and CMV in the blood and urine, and will be interviewed about their vision and how it affects daily activities.
Study identification
- NCT ID
- NCT00001611
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 15 participants
Conditions and interventions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 1997
- Primary completion
- Not listed
- Completion
- Mar 31, 2004
- Last update posted
- Mar 3, 2008
1997 – 2004
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Eye Institute (NEI) | 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 NCT00001611, 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 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00001611 live on ClinicalTrials.gov.