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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001034
• Other study ID #: CPCRA 023
• Secondary ID: 11573
• Status: Completed
• Phase: Phase 2
• Est. completion date: August 1995

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: August 1995
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• Digestive System Diseases
• Gastrointestinal Diseases
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Bronx Lebanon Hosp Ctr	Bronx	New York
United States	Addiction Research and Treatment Corp	Brooklyn	New York
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Comprehensive AIDS Alliance of Detroit	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Schering - Plough Corp	Kenilworth	New Jersey
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	Clinical Directors Network of Region II	New York	New York
United States	Harlem AIDS Treatment Group / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Richmond AIDS Consortium	Richmond	Virginia
United States	Community Consortium of San Francisco	San Francisco	California
United States	Veterans Administration Med Ctr / Regional AIDS Program	Washington	District of Columbia
United States	Wilmington Hosp / Med Ctr of Delaware	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (2)

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)

Brosgart CL, Louis TA, Hillman DW, Craig CP, Alston B, Fisher E, Abrams DI, Luskin-Hawk RL, Sampson JH, Ward DJ, Thompson MA, Torres RA. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. Terry Beirn Community Programs for Clinical Research on AIDS. AIDS. 1998 Feb 12;12(3):269-77. — View Citation