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Sponsored by: |
Gilead Sciences |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002437 |
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Cidofovir Drug: Probenecid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | A Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral Cytomegalovirus Retinitis in Patients With AIDS |
Estimated Enrollment: | 48 |
Patients are randomized to one of two treatment arms. Group A receives HPMPC by IV infusion weekly for 2 consecutive weeks (induction) and then every other week (maintenance) with oral probenecid and IV hydration.
Group B receives no treatment until the time of retinitis progression (deferred treatment), at which time they receive the same regimen as Group A, provided retinitis progression is not immediately sight-threatening.
Ages Eligible for Study: | 13 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded:
Excluded within 1 week prior to study entry:
United States, California | |
UCI Med Ctr | |
Orange, California, United States, 92668 | |
Mount Zion Med Ctr | |
San Francisco, California, United States, 94115 | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, Massachusetts | |
Beth Israel Hosp | |
Boston, Massachusetts, United States, 02215 | |
United States, New Jersey | |
Besselaar Associates | |
Princeton, New Jersey, United States, 085406681 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14607 | |
United States, North Carolina | |
Univ of North Carolina Hosps | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Texas | |
Audie L Murphy Veterans Administration Hosp | |
San Antonio, Texas, United States, 78284 | |
United Kingdom | |
Charing Cross and Westminster Med School | |
London SW 10, United Kingdom |
Study ID Numbers: | 216A, GS-93-106 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002437 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Retinitis Probenecid Drug Therapy, Combination Cytomegalovirus Infections |
Acquired Immunodeficiency Syndrome Antiviral Agents cidofovir |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Retinitis Cytomegalovirus Anti-Retroviral Agents Cytomegalic Inclusion Disease Probenecid Cytomegalovirus Infections Retroviridae Infections Retinal Diseases Cidofovir Anti-HIV Agents Eye Diseases |
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Antiviral Agents Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Radiation-Sensitizing Agents HIV Infections Sexually Transmitted Diseases DNA Virus Infections Antirheumatic Agents |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Physiological Effects of Drugs Retinitis Renal Agents Infection Gout Suppressants Anti-Retroviral Agents Therapeutic Uses Probenecid Cytomegalovirus Infections Retroviridae Infections Retinal Diseases |
Cidofovir RNA Virus Infections Anti-HIV Agents Immune System Diseases Eye Infections, Viral Eye Diseases Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome Eye Infections Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Radiation-Sensitizing Agents |