Cytomegalovirus Infection |
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Clinical Trial: A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
This study is no longer recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Cytomegalovirus Retinitis HIV Infections | Drug: Ganciclovir | Phase III |
MedlinePlus related topics: AIDS; Cytomegalovirus Infections; Eye Diseases; Retinal Disorders; Viral Infections
Study Type: Interventional
Study Design: Treatment, Open Label
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 above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria
Concurrent Medication: Allowed:
- Aerosolized pentamidine prophylaxis for Pneumocystis carinii pneumonia.
- Topical ophthalmics.
- Topical acyclovir.
Concurrent Treatment: Allowed:
- Hemodialysis for patients with renal impairment.
Patients must have:
- Diagnosis of AIDS and immediately sight-threatening cytomegalovirus retinitis.
Prior Medication: Allowed:
- Zidovudine.
- Prior therapy for retinitis.
Exclusion Criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded:
- Non-immediately sight-threatening cytomegalovirus retinitis.
Concurrent Medication: Excluded:
- Systemic investigational agents such as antimetabolites, alkylating agents, nucleoside analogs, acyclovir sodium (Zovirax).
- Interferon.
- Cytokines.
- Foscarnet (non-nucleoside pyrophosphate analog).
- Ganciclovir may be withheld for up to 21 days for an acute course with an investigational or toxic therapy or oral / IV acyclovir.
Patients with the following are excluded:
- Non-immediately sight-threatening cytomegalovirus retinitis.
Location Information
Maryland
Natl Inst of Allergy & Infect Dis / Cln Ctr, Bethesda, Maryland, 20892, United States
Feinberg J, Study Chair
More Information
Click here for more information about Ganciclovir
Publications
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)
Record last reviewed: April 1992
Last Updated: April 7, 2005
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000698
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- CMV (Centers for Disease Control and Prevention)
- Cytomegalic Inclusion Body Disease (National Institute of Neurological Disorders and Stroke)

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