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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000688 |
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 |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control |
Official Title: | A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS |
Estimated Enrollment: | 180 |
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:
Patients must have:
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:
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 | |
Stanford Univ School of Medicine | |
Stanford, California, United States, 94305 | |
Mills Hosp | |
San Mateo, California, United States, 94401 | |
Pacific Presbyterian | |
San Francisco, California, United States, 94118 | |
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 | |
Plaza Med Ctr | |
Houston, Texas, United States, 77004 | |
Infectious Diseases Association of Houston / Methodist Hosp | |
Houston, Texas, United States, 77030 | |
Univ TX Galveston Med Branch | |
Galveston, Texas, United States, 77550 | |
United States, Virginia | |
Infectious Disease Physicians Inc | |
Annandale, Virginia, United States, 22203 |
Study Chair: | Spector SA | |
Study Chair: | Jabs D |
Study ID Numbers: | ACTG 071, RS-21592, ICM 1697 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000688 |
Health Authority: | United States: Federal Government |
Retinitis Injections, Intravenous Ganciclovir Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |