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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001034

Collaborator

Hoffmann-La Roche (Industry)

850

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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

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 Design

Study Type:

Interventional

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 :

Aug 1, 1995

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium of San Francisco	San Francisco	California	United States	94110
2	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	80204
3	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware	United States	19899
4	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia	United States	20422
5	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
6	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
7	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
8	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan	United States	48201
9	Henry Ford Hosp	Detroit	Michigan	United States	48202
10	Schering - Plough Corp	Kenilworth	New Jersey	United States	07033
11	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
12	Bronx Lebanon Hosp Ctr	Bronx	New York	United States	10456
13	Addiction Research and Treatment Corp	Brooklyn	New York	United States	11201
14	Clinical Directors Network of Region II	New York	New York	United States	10011
15	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York	United States	10037
16	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon	United States	97210
17	Richmond AIDS Consortium	Richmond	Virginia	United States	23298