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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000698 |
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 |
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.
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:
Study ID Numbers: | TX 303 |
Study First Received: | November 2, 1999 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00000698 |
Health Authority: | United States: Federal Government |
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Opportunistic Infections Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |