Clinical trial NCT00002330: A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
Official title: A Randomized Study Comparing the Safety and Efficacy of Three Doses of Oral Ganciclovir to Intravenous Ganciclovir for the Maintenance Treatment of Cytomegalovirus Retinitis in People With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 280
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the time to progression of Cytomegalovirus (CMV) retinitis among each of three doses of oral ganciclovir, as well as to intravenous therapy, when given as maintenance for 26 weeks. To compare the safety and tolerance among oral doses of ganciclovir at the study doses, as well as to intravenous therapy, when administered as maintenance for 26 weeks.

Detailed description: Patients who have received anti-CMV therapy with intravenous ganciclovir for at least 4 weeks that resulted in stable retinitis are randomized to receive one of three doses of oral ganciclovir or intravenous ganciclovir for 26 weeks of maintenance.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical and ophthalmic nucleoside analogues.

Patients must have:

* HIV positive.
* No more than two episodes of CMV retinitis progression (relapse resulting in reinduction with intravenous anti-CMV therapy) since the original retinitis diagnosis.
* Currently stable retinitis.

Prior Medication:

Allowed:

* Foscarnet prior to the 4 weeks of intravenous induction therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Persistent or clinically significant diarrhea, nausea, or abdominal pain.
* Severe odynophagia.
* Other gastrointestinal (GI) symptoms or uncontrolled GI disease.
* Active CMV disease of the GI tract (e.g., CMV colitis, CMV esophagitis).
* Ocular media opacities (corneal, lenticular, or vitreal) that prevent ophthalmologic retinal assessments.
* Dementia, decreased mentation, or other encephalopathic signs and symptoms that would preclude informed consent or study compliance.

Concurrent Medication:

Excluded:

* Acyclovir sodium (Zovirax) by any route other than topical.
* Valacyclovir.
* Brovavir.
* Vidarabine.
* Amantadine hydrochloride.
* Cytarabine.
* Idoxuridine.
* Ribavirin.
* Interferon.
* Foscarnet (non-nucleoside pyrophosphate analogue).
* CMV hyperimmune globulin.
* Soluble CD4.
* Trichosanthin (Compound Q).
* Imipenem-cilastatin.
* Isoprinosine.
* Levamisole.
* Other investigational drugs.

Patients with the following prior condition are excluded:

History of hypersensitivity to acyclovir or ganciclovir.

Prior Medication:

Excluded:

* More than three induction regimens with intravenous anti-CMV therapy.
* Any prior oral ganciclovir.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham / AIDS Outpatient Clinic
state: Alabama
city: Phoenix
country: United States
facility: McDowell Clinic
state: Arizona
city: Phoenix
country: United States
facility: Dr Ken Fisher
state: Arizona
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Los Angeles
country: United States
facility: AIDS Clinical Research Ctr / UCLA Med Ctr
state: California
city: San Diego
country: United States
facility: UCSD Med Ctr / Pediatrics
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: San Francisco
country: United States
facility: Mount Zion Med Ctr / UCSF
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Coral Gables
country: United States
facility: Community Research Initiative
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Honolulu
country: United States
facility: Margo Heath - Chiozzi
state: Hawaii
city: Baltimore
country: United States
facility: Univ of Maryland School of Medicine
state: Maryland
city: St. Louis
country: United States
facility: AIDS Clinical Trials Unit
state: Missouri
city: Las Vegas
country: United States
facility: HIV Wellness Ctr / Univ Med Ctr
state: Nevada
city: Albuquerque
country: United States
facility: Univ of New Mexico
state: New Mexico
city: Sante Fe
country: United States
facility: AIDS Wellness Clinic
state: New Mexico
city: New York
country: United States
facility: Dr Dorothy Friedberg
state: New York
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
city: Chapel Hill
country: United States
facility: Univ of North Carolina School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Nalle Clinic
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve Univ
state: Ohio
city: Columbus
country: United States
facility: Ohio State Univ Hosp
state: Ohio
city: Tulsa
country: United States
facility: Associates Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Philadelphia
country: United States
facility: Buckley Braffman Stern Med Associates
state: Pennsylvania
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Dallas
country: United States
facility: N Texas Ctr for AIDS & Clin Rsch
state: Texas
city: El Paso
country: United States
facility: Texas Tech Health Sciences Ctr
state: Texas
city: Fort Worth
country: United States
facility: Dr Daniel Barbero
state: Texas
city: Houston
country: United States
facility: Infectious Diseases Association of Houston
state: Texas
city: San Antonio
country: United States
facility: Audie L Murphy Veterans Administration Hosp
state: Texas
city: Vancouver
country: Canada
facility: Saint Paul's Hosp
state: British Columbia
Study officials:
References:
citation: Lalezari J, Friedberg D, Bisset J, Giordano M, Hardy D, Robinson C. A comparison of the safety and efficacy of 3g, 4.5g and 6g doses of oral ganciclovir versus IV ganciclovir for maintenance treatment of CMV retinitis. Int Conf AIDS. 1996 Jul 7-12;11(2):226 (abstract no ThB305)