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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000698 |
Purpose
To determine the safety and effectiveness of intravenous ganciclovir (also known as DHPG) in the treatment of sight-threatening cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.
| Condition | Intervention | Phase |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Phase III |
| MedlinePlus related topics: | AIDS Cytomegalovirus Infections |
| Drug Information available for: | Ganciclovir Ganciclovir sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis |
| Study Completion Date: | August 2007 |
CMV retinitis is a severe vision-threatening viral infection of the retina of the eye. It occurs in patients whose immune function has been impaired and is the most common cause of blindness in patients with AIDS. Ganciclovir (GCV) improved the signs and symptoms of CMV retinitis in approximately 80 percent of the patients treated for 2 weeks, but almost all of the patients treated with GCV had a relapse after treatment was stopped. Thus, it is important to determine if GCV can be safely given over a long period of time (maintenance therapy) and if it is effective in preventing a relapse of CMV retinitis.
Patients are given GCV intravenously for 14 days. Then the patient receives the same dose, but only once a day, for as long as therapy is tolerated. If the retinitis worsens during the maintenance phase, the patient may again be given GCV for 14 days. Long-term treatment with GCV usually requires the surgical placement of a catheter in a large central vein in the chest or groin that is left in place indefinitely. If this is required, the procedure will be explained to the patient.
Eligibility
| Ages Eligible for Study: | 3 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Contacts and Locations More Information
Click here for more information about Ganciclovir
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Feinberg J, Katz D, Mastre B, DeArmond B. Ganciclovir (GCV) in AIDS patients with immediately sight-threatening CMV retinitis (ISTCR): initial summary of "treatment IND" data. Int Conf AIDS. 1990 Jun 20-23;6(1):230 (abstract no ThB432)
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| Study ID Numbers: | TX 303 |
| First Received: | November 2, 1999 |
| Last Updated: | September 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000698 |
| Health Authority: | United States: Federal Government |
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