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An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002135
First Posted: August 31, 2001
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
March 17, 2014
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No Changes Posted
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An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access
To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.
Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.
Interventional
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Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Ganciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Patients must have:

  • AIDS.
  • Stable CMV retinitis.
  • Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.
  • No permanent central IV catheter at present.
  • Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.
  • Consent of guardian if less than legal age of consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Require continuation of concomitant medications precluded by this protocol.

Concurrent Medication:

Excluded:

  • Intravitreal anti-CMV treatment.
  • Any other concomitant medications precluded by the protocol.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002135
037C
GANS2224
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
November 1995

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP