A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
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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 | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Phase 3 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS |
Estimated Enrollment: | 180 |
Primary Completion Date: | February 1995 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
United States, California | |
Univ of California / San Diego Treatment Ctr | |
San Diego, California, United States, 921036325 | |
Stanford at Kaiser / Kaiser Permanente Med Ctr | |
San Francisco, California, United States, 94115 | |
Mount Zion Med Ctr | |
San Francisco, California, United States, 94115 | |
Pacific Presbyterian | |
San Francisco, California, United States, 94118 | |
Mills Hosp | |
San Mateo, California, United States, 94401 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Illinois | |
Rush Presbyterian - Saint Luke's Med Ctr | |
Chicago, Illinois, United States, 60612 | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Indiana | |
Indiana Univ Hosp | |
Indianapolis, Indiana, United States, 462025250 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
United States, Minnesota | |
Univ of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Kansas City Veterans Administration Med Ctr | |
Kansas City, Missouri, United States, 64128 | |
Washington Univ Med Ctr | |
St Louis, Missouri, United States, 63110 | |
United States, New Mexico | |
Univ of New Mexico Hlth Sciences Ctr / Dept of Med | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
New York Univ Med Ctr / Dept of Environmental Med | |
New York, New York, United States, 10016 | |
United States, Ohio | |
Holmes Hosp / Univ of Cincinnati Med Ctr | |
Cincinnati, Ohio, United States, 452670405 | |
United States, Texas | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 | |
Plaza Med Ctr | |
Houston, Texas, United States, 77004 | |
Infectious Diseases Association of Houston / Methodist Hosp | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 |
Study Chair: | Spector SA | |
Study Chair: | Jabs D |
Additional Information:
Publications:
ClinicalTrials.gov Identifier: | NCT00000688 History of Changes |
Other Study ID Numbers: | ACTG 071, RS-21592, ICM 1697 |
Study First Received: | November 2, 1999 |
Last Updated: | March 11, 2011 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis Injections, Intravenous Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013