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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.

Sponsored by: Roche Global Development
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002330
  Purpose

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.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Ganciclovir

MedlinePlus related topics:   AIDS    Cytomegalovirus Infections   

Drug Information available for:   Ganciclovir    Ganciclovir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   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

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:   280

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002330

Show 36 study locations  Show 36 Study Locations

Sponsors and Collaborators
Roche Global Development
  More Information


Publications:
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)
 

Study ID Numbers:   059F, GANs2226
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002330
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis  
Ganciclovir  
Cytomegalovirus Infections  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
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
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 December 03, 2008




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