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
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  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)

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

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Ganciclovir
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014