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A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
This study has been completed.
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
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir
Phase III

MedlinePlus related topics: AIDS Cytomegalovirus Infections
Drug Information available for: Ganciclovir Ganciclovir sodium
U.S. FDA Resources
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Study Completion Date: August 2007
Detailed Description:

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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000698

Locations
United States, Maryland
Natl Inst of Allergy & Infect Dis / Cln Ctr
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Study Chair: Feinberg J
  More Information

Click here for more information about Ganciclovir  This link exits the ClinicalTrials.gov site

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)

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

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
AIDS-Related Opportunistic Infections
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Eye Infections, Viral
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009