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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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections Gastrointestinal Diseases |
Drug: Ganciclovir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study 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 |
| Estimated Enrollment: | 850 |
| Study Completion Date: | August 1995 |
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.
Eligibility| Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00001034
| United States, California | |
| Community Consortium of San Francisco | |
| San Francisco, California, United States, 94110 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 80204 | |
| United States, Delaware | |
| Wilmington Hosp / Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr / Regional AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| United States, Louisiana | |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Michigan | |
| Comprehensive AIDS Alliance of Detroit | |
| Detroit, Michigan, United States, 48201 | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, New Jersey | |
| Schering - Plough Corp | |
| Kenilworth, New Jersey, United States, 07033 | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 07103 | |
| United States, New York | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10456 | |
| Addiction Research and Treatment Corp | |
| Brooklyn, New York, United States, 11201 | |
| Clinical Directors Network of Region II | |
| New York, New York, United States, 10011 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 97210 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23298 | |
| Study Chair: | Brosgart C | |
| Study Chair: | Craig C |
More Information
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001034 History of Changes |
| Other Study ID Numbers: | CPCRA 023 11573 |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 28, 2013 |
| Health Authority: | United States: Federal Government |
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:
|
HIV Infections Retinitis Gastrointestinal Diseases Digestive System Diseases Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System 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 |
ClinicalTrials.gov processed this record on September 29, 2016