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| Sponsor: | Roche Global Development |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002134 |
Purpose
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 |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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 |
Eligibility| 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:
Contacts and Locations| United States, California | |
| Dr Neil Brourman | |
| Beverly Hills, California, United States, 90211 | |
| UCI College of Medicine | |
| Irvine, California, United States, 92715 | |
| Estelle Doheny Eye Clinic | |
| Los Angeles, California, United States, 90033 | |
| Dr Robert T Wendel | |
| Sacramento, California, United States, 95819 | |
| Kaiser Hosp | |
| San Francisco, California, United States, 94115 | |
| Pacific Horizons Med Group | |
| San Francisco, California, United States, 94115 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 95128 | |
| Dr Robert Avery | |
| Santa Barbara, California, United States, 93103 | |
| Harbor - UCLA Med Ctr | |
| Torrance, California, United States, 90509 | |
| United States, District of Columbia | |
| Dr Alan Palestine | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Florida | |
| Dr Michael Stewart | |
| Jacksonville, Florida, United States, 32204 | |
| Bascom Palmer | |
| Miami, Florida, United States, 33136 | |
| 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 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00002134 History of Changes |
| Other Study ID Numbers: | 037B, GANS2304 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Retinitis Ganciclovir Administration, Oral Acquired Immunodeficiency Syndrome |
|
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 |