The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
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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 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
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.
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Ages Eligible for Study: | 13 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Antiretroviral agents.
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
- Rifabutin.
- Filgrastim (G-CSF).
- p24 vaccine.
Patients must have:
- Diagnosis of AIDS by CDC criteria.
- Diagnosis of peripheral (not immediately sight-threatening) CMV retinitis.
- Visual acuity in the affected eye of >= three lines on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 1 m distance.
- Life expectancy of at least 3 months.
- Consent of parent or guardian in patients less than 18 years of age.
Prior Medication:
Allowed:
- Acyclovir.
- Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin if given solely as prophylaxis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Media opacity that precludes visualization of the fundus of both eyes.
- Retinal detachment.
- Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- Active medical problems considered sufficient to hinder study compliance.
- Known clinically significant allergy to probenecid.
Concurrent Medication:
Excluded:
- Acyclovir (may be reinstituted following development of herpetic lesions).
- Ganciclovir.
- Foscarnet.
- Amphotericin B.
- Diuretics.
- Aminoglycoside antibiotics.
- CMV hyperimmune immunoglobulin.
- Intravenous pentamidine.
- Other nephrotoxic agents.
- Other investigational drugs with potential nephrotoxicity.
Prior Medication:
Excluded:
- Prior ganciclovir, foscarnet, or CMV hyperimmune immunoglobulin as therapy for CMV disease (although permitted if previously received solely as prophylaxis).
Excluded within 1 week prior to study entry:
- Amphotericin B.
- Vidarabine.
- Other nephrotoxic agents.
- Aminoglycoside antibiotics.
- Intravenous pentamidine. Drug or alcohol abuse.
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United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
UCI Med Ctr | |
Orange, California, United States, 92668 | |
Mount Zion Med Ctr | |
San Francisco, California, United States, 94115 | |
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 |
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Publications:
ClinicalTrials.gov Identifier: | NCT00002437 History of Changes |
Other Study ID Numbers: | 216A, GS-93-106 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Retinitis Probenecid Drug Therapy, Combination Cytomegalovirus Infections |
Acquired Immunodeficiency Syndrome Antiviral Agents cidofovir |
Additional relevant MeSH terms:
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 Probenecid Cidofovir Uricosuric Agents Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Renal Agents Antineoplastic Agents Antiviral Agents |
ClinicalTrials.gov processed this record on March 10, 2013