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A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis - Article


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Ganciclovir Oral

Cytoveve Capsules


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.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

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

Further Study Details: 

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:

Prior Medication: Allowed:

  • Zidovudine.
  • Prior therapy for retinitis.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

Concurrent Medication: Excluded:

Patients with the following are excluded:


Location Information


Maryland
      Natl Inst of Allergy & Infect Dis / Cln Ctr, Bethesda,  Maryland,  20892,  United States

Study chairs or principal investigators

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)

Study ID Numbers:  TX 303
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


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September 8, 2008



Page Updated: June 1, 2005
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