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The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

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.
 
ClinicalTrials.gov Identifier: NCT00001034
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 1, 2013
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression.

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Retinitis HIV Infections Gastrointestinal Diseases Drug: Ganciclovir Phase 2

Detailed Description:

The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.

Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 850 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Comparative, Placebo-Controlled Trial of the Safety and Efficacy of Oral Ganciclovir for Prophylaxis of Cytomegalovirus (CMV) Retinal and Gastrointestinal Mucosal Disease in HIV-Infected Individuals With Severe Immunosuppression
Actual Study Completion Date : August 1995






Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretroviral therapy.
  • Anti-PCP prophylaxis.
  • Maintenance or prophylaxis therapy for other opportunistic infections besides CMV.

Patients must have:

  • Working diagnosis of HIV infection.
  • CD4 count <= 100 cells/mm3.
  • Positive CMV serology (IgG) or CMV culture, in the absence of active disease, documented at any time prior to study entry.
  • Reasonably good health.
  • Life expectancy of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Acute life-threatening illness.
  • Active lymphoma.
  • Hypersensitivity to acyclovir.
  • Lack of willingness or ability, in the opinion of the clinician, to comply with protocol requirements.

Concurrent Medication:

Excluded:

  • Vidarabine.
  • Amantadine hydrochloride (Symmetrel).
  • CMV hyperimmune globulin/intravenous immune globulin.
  • Cytarabine.
  • Fiacitabine (FIAC) or fialuridine (FIAU).
  • Foscarnet.
  • Intravenous ganciclovir.
  • HPMPC.
  • Idoxuridine.
  • Intravenous acyclovir.
  • Oral acyclovir at > 1 g/day.
  • Other drugs with potential anti-CMV activity.

Prior Medication:

Excluded within 60 days prior to study entry:

  • Foscarnet.

Excluded within 2 weeks prior to study entry:

  • Vidarabine.
  • Amantadine hydrochloride (Symmetrel).
  • CMV hyperimmune globulin/intravenous immune globulin.
  • Cytarabine.
  • Fiacitabine (FIAC) or fialuridine (FIAU).
  • Ganciclovir.
  • HPMPC.
  • Idoxuridine.
  • Intravenous acyclovir.
  • Oral acyclovir at > 1 g/day.
  • Other drugs with potential anti-CMV activity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001034


Locations
Show Show 17 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Hoffmann-La Roche
Investigators
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Study Chair: Brosgart C
Study Chair: Craig C

Publications:
Brosgart C, Craig C, Louis TA, Hillman D, Costanzo L, Timpone J, Scott J, Nunley F, Stempien MJ. Design and demographics in a multicenter trial of cytomegalovirus (CMV) prophylaxis in advanced HIV disease. Int Conf AIDS. 1994 Aug 7-12;10(2):10 (abstract no 331B)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001034    
Other Study ID Numbers: CPCRA 023
11573 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
Ganciclovir
Cytomegalovirus Infections
Administration, Oral
Acquired Immunodeficiency Syndrome
Gastrointestinal System
Additional relevant MeSH terms:
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Cytomegalovirus Retinitis
Gastrointestinal Diseases
Retinitis
Digestive System Diseases
Virus Diseases
Retinal Diseases
Eye Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Eye Infections, Viral
Eye Infections
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action