A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00000688

Collaborator

Hoffmann-La Roche (Industry)

180

Enrollment

Locations

8.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Actual Primary Completion Date :

Feb 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	921036325
2	Mount Zion Med Ctr	San Francisco	California	United States	94115
3	Stanford at Kaiser / Kaiser Permanente Med Ctr	San Francisco	California	United States	94115
4	Pacific Presbyterian	San Francisco	California	United States	94118
5	Mills Hosp	San Mateo	California	United States	94401
6	Stanford Univ School of Medicine	Stanford	California	United States	94305
7	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
8	Northwestern Univ Med School	Chicago	Illinois	United States	60611
9	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
10	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
11	Henry Ford Hosp	Detroit	Michigan	United States	48202
12	Univ of Minnesota	Minneapolis	Minnesota	United States	55455
13	Kansas City Veterans Administration Med Ctr	Kansas City	Missouri	United States	64128
14	Washington Univ Med Ctr	St Louis	Missouri	United States	63110
15	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico	United States	87131
16	New York Univ Med Ctr / Dept of Environmental Med	New York	New York	United States	10016
17	Cornell Univ Med Ctr	New York	New York	United States	10021
18	Holmes Hosp / Univ of Cincinnati Med Ctr	Cincinnati	Ohio	United States	452670405
19	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
20	Plaza Med Ctr	Houston	Texas	United States	77004
21	Infectious Diseases Association of Houston / Methodist Hosp	Houston	Texas	United States	77030
22	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203