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
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| ClinicalTrials.gov Identifier: NCT00001034 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 4, 2021
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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 |
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.
| 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 |
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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 |
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.
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
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| Study Chair: | Brosgart C | ||
| Study Chair: | Craig C |
| 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: | November 4, 2021 |
| Last Verified: | October 2021 |
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Retinitis Ganciclovir Cytomegalovirus Infections |
Administration, Oral Acquired Immunodeficiency Syndrome Gastrointestinal System |
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Cytomegalovirus Infections Cytomegalovirus Retinitis Gastrointestinal Diseases Digestive System Diseases Retinitis Infections Virus Diseases Retinal Diseases Eye Diseases 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 |