Clinical trial NCT00000688: A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Official title: A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Injections, Intravenous
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Hoffmann-La Roche
First posted: 2001-08-31
Enrollment: 180
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To provide information about the usefulness and safety of giving injections of ganciclovir (DHPG) for treating peripheral cytomegalovirus (CMV) retinitis.

CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Detailed description: CMV retinitis is an important sight-threatening opportunistic infection which affects 1 to 2 out of every 10 patients with AIDS. Results from an earlier study suggest that about 80 percent of patients with CMV retinitis will be helped by receiving intravenous doses of DHPG.

Patients are randomly placed in one of two treatment groups. In one group, patients receive DHPG twice a day, intravenously, for 14 days, followed by a daily dose for 14 weeks. Patients in the other group (the delayed-treatment group) do not receive immediate treatment with DHPG. Patients in both groups have regular ophthalmologic (eye) evaluations with retinal photographs to see if the retinitis is getting worse. Patients in the delayed treatment group receive DHPG if this occurs.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT) for patients in delayed treatment group and not receiving ganciclovir.
* Didanosine (ddI) may be continued or initiated in any patient during the study.
* Topical acyclovir.
* Topical ophthalmics.
* Aerosolized pentamidine.

Patients must have:

* AIDS as defined by the CDC criteria or have had confirmation of HIV infection by ELISA, p24 antigen assay, or culture of HIV.
* Retinal lesions greater than 1500 microns from edge of optic disc outside major temporal vascular arcades, and greater than 3000 microns from fovea.
* Understanding of study provisions, and willingness to sign informed consent form approved by the appropriate Institutional Review Board and Syntex.
* Life expectancy of at least 4 months.

Exclusion Criteria

Co-existing Condition:

Patients with ocular conditions requiring immediate surgical correction are excluded.

Concurrent Medication:

Excluded during first 4 weeks of ganciclovir treatment:

Zidovudine (AZT).

Excluded:

Other investigational drugs and antimetabolites, alkylating agents, nucleoside analogs (topical ophthalmics are permitted), acyclovir, interferon, foscarnet (non-nucleoside pyrophosphate analog), cytomegalovirus (CMV) hyperimmune globulin, and cytokines.

Patients with the following are excluded:

* Immediately sight-threatening retinitis (= or \< 1500 microns from edge of optic disc, or inside major temporal vascular arcades, or = or \< 3000 microns from the fovea).
* Ocular media opacities (corneal, lenticular, or vitreal) preventing ophthalmologic and photographic retinal assessment.
* Demonstrated hypersensitivity to acyclovir.

Prior Medication:

Excluded:

- Previous treatment with anti-cytomegalovirus therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Univ of California / San Diego Treatment Ctr
state: California
city: San Francisco
country: United States
facility: Mount Zion Med Ctr
state: California
city: San Francisco
country: United States
facility: Stanford at Kaiser / Kaiser Permanente Med Ctr
state: California
city: San Francisco
country: United States
facility: Pacific Presbyterian
state: California
city: San Mateo
country: United States
facility: Mills Hosp
state: California
city: Stanford
country: United States
facility: Stanford Univ School of Medicine
state: California
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern Univ Med School
state: Illinois
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Hosp
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Hosp
state: Michigan
city: Minneapolis
country: United States
facility: Univ of Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Veterans Administration Med Ctr
state: Missouri
city: St Louis
country: United States
facility: Washington Univ Med Ctr
state: Missouri
city: Albuquerque
country: United States
facility: Univ of New Mexico Hlth Sciences Ctr / Dept of Med
state: New Mexico
city: New York
country: United States
facility: New York Univ Med Ctr / Dept of Environmental Med
state: New York
city: New York
country: United States
facility: Cornell Univ Med Ctr
state: New York
city: Cincinnati
country: United States
facility: Holmes Hosp / Univ of Cincinnati Med Ctr
state: Ohio
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Plaza Med Ctr
state: Texas
city: Houston
country: United States
facility: Infectious Diseases Association of Houston / Methodist Hosp
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
Study officials:
name: Spector SA
role: STUDY_CHAIR
name: Jabs D
role: STUDY_CHAIR
References:
citation: Spector SA, Weingeist T, Pollard RB, Dieterich DT, Samo T, Benson CA, Busch DF, Freeman WR, Montague P, Kaplan HJ, et al. A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS. AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group. J Infect Dis. 1993 Sep;168(3):557-63. doi: 10.1093/infdis/168.3.557.