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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Northwestern University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004794 |
OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis.
II. Obtain safety and efficacy data related to different dosages of cidofovir.
Condition | Intervention | Phase |
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Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome |
Drug: cidofovir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 90 |
Study Start Date: | March 1995 |
PROTOCOL OUTLINE: This is a randomized study. Cidofovir is administered intravenously. Treatment ideally begins within 24 hours of randomization.
In the first group, therapy is deferred until disease progression. Patients are then treated according to best medical judgement, which includes the option of cidofovir therapy. The second group receives induction with cidofovir every 7 days for 2 weeks, then begins maintenance with a low dose given every 14 days until dose-limiting toxicity or disease progression occurs. The third group receives the same cidofovir induction followed by a high maintenance dose given every 14 days until dose-limiting toxicity or disease progression occurs. Probenecid and intravenous hydration are administered concurrently with cidofovir.
Patients are followed for progression and survival every 2 weeks for 23 weeks, then every 12 weeks. At disease progression, patients may be re-treated with another course of induction and maintenance.
Ages Eligible for Study: | 13 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
No probenecid allergy No medical problems sufficient to hinder compliance with therapy or follow- up, including drug or alcohol abuse No pregnant or nursing women Negative serum pregnancy test required of fertile women Adequate birth control required of fertile patients during and for 3 months after study
Study ID Numbers: | 199/11927, NU-506 |
Study First Received: | February 24, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004794 History of Changes |
Health Authority: | United States: Federal Government |
cytomegalovirus retinitis ophthalmologic disorders rare disease |
Cidofovir Sexually Transmitted Diseases, Viral Anti-HIV Agents Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Rare Diseases Antiviral Agents Cytomegalovirus Immunologic Deficiency Syndromes |
Herpesviridae Infections Virus Diseases Anti-Retroviral Agents Radiation-Sensitizing Agents HIV Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections Retinal Diseases |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Physiological Effects of Drugs Retinitis Pathologic Processes Anti-Retroviral Agents Therapeutic Uses Syndrome Cytomegalovirus Infections Retroviridae Infections Retinal Diseases Cidofovir RNA Virus Infections |
Anti-HIV Agents Disease 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 HIV Infections |