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Sponsored by: |
Roche Global Development |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002134 |
To demonstrate the efficacy of oral ganciclovir in preventing new cytomegalovirus (CMV) disease in AIDS patients with unilateral CMV retinitis treated with an intravitreal ganciclovir implant. To compare safety and tolerance, time to progression, quality of life, and survival among patients treated with an intravitreal ganciclovir implant, with and without oral ganciclovir, versus standard intravenous (IV) ganciclovir therapy.
Condition | Intervention |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis |
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 the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, California | |
Pacific Horizons Med Group | |
San Francisco, California, United States, 94115 | |
Dr Robert Avery | |
Santa Barbara, California, United States, 93103 | |
Dr Neil Brourman | |
Beverly Hills, California, United States, 90211 | |
Estelle Doheny Eye Clinic | |
Los Angeles, California, United States, 90033 | |
Harbor - UCLA Med Ctr | |
Torrance, California, United States, 90509 | |
Santa Clara Valley Med Ctr | |
San Jose, California, United States, 95128 | |
Dr Robert T Wendel | |
Sacramento, California, United States, 95819 | |
Kaiser Hosp | |
San Francisco, California, United States, 94115 | |
UCI College of Medicine | |
Irvine, California, United States, 92715 | |
United States, District of Columbia | |
Dr Alan Palestine | |
Washington, District of Columbia, United States, 20036 | |
United States, Florida | |
Bascom Palmer | |
Miami, Florida, United States, 33136 | |
Dr Michael Stewart | |
Jacksonville, Florida, United States, 32204 | |
United States, Georgia | |
Emory Eye Clinic | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Dr David Weinberg | |
Chicago, Illinois, United States, 60611 | |
United States, Kentucky | |
Univ of Kentucky Med Ctr | |
Lexington, Kentucky, United States, 40536 | |
United States, Massachusetts | |
New England Med Ctr / Tufts Univ | |
Boston, Massachusetts, United States, 02111 | |
United States, New York | |
Dr Dorothy Friedberg | |
New York, New York, United States, 10016 | |
New York Hosp | |
New York, New York, United States, 10021 | |
Saint Clare's Prof Office | |
New York, New York, United States, 10019 | |
Vitreo - Retinal Consultants | |
New York, New York, United States, 10028 | |
United States, Texas | |
Univ of Texas Southwestern Med Ctr of Dallas | |
Dallas, Texas, United States, 75235 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Univ of Washington Med Ctr | |
Seattle, Washington, United States, 98195 |
Study ID Numbers: | 037B, GANS2304 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002134 |
Health Authority: | United States: Food and Drug Administration |
Retinitis Ganciclovir Administration, Oral 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 |