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A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002330
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002330 on ClinicalTrials.gov Archive Site
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A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS

To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Interventional
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Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
Drug: Ganciclovir
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Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Topical and ophthalmic nucleoside analogues.

Patients must have:

  • HIV positive.
  • No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
  • Currently stable retinitis.

Prior Medication:

Allowed:

  • Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Persistent or clinically significant diarrhea, nausea, or abdominal pain.
  • Severe odynophagia.
  • Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
  • Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
  • Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
  • Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

  • Acyclovir sodium (Zovirax) by any route other than topical.
  • Valacyclovir.
  • Brovavir.
  • Vidarabine.
  • Amantadine hydrochloride.
  • Cytarabine.
  • Idoxuridine.
  • Ribavirin.
  • Interferon.
  • Foscarnet (non-nucleoside pyrophosphate analogue).
  • CMV hyperimmune globulin.
  • Soluble CD4.
  • Trichosanthin (Compound Q).
  • Imipenem-cilastatin.
  • Isoprinosine.
  • Levamisole.
  • Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

  • More than three induction regimens with intravenous anti-CMV therapy.
  • Any prior oral ganciclovir.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002330
059F, GANs2226
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Roche Global Development
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NIH AIDS Clinical Trials Information Service
April 1996

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