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:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002135
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1995

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002135 on ClinicalTrials.gov Archive Site
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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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Endpoint Classification: Safety Study
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.

Both
13 Years and older
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