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The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

NCT ID: NCT00002437

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Cidofovir

Intervention Type DRUG

Probenecid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Locations

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Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Site Status

UCI Med Ctr

Orange, California, United States

Site Status

Mount Zion Med Ctr

San Francisco, California, United States

Site Status

Beth Israel Hosp

Boston, Massachusetts, United States

Site Status

Besselaar Associates

Princeton, New Jersey, United States

Site Status

Univ of Rochester Med Ctr

Rochester, New York, United States

Site Status

Univ of North Carolina Hosps

Chapel Hill, North Carolina, United States

Site Status

Audie L Murphy Veterans Administration Hosp

San Antonio, Texas, United States

Site Status

Charing Cross and Westminster Med School

London Southwest 10, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Lalezari J, et al. A phase II/III randomized study of immediate versus deferred intravenous (IV) cidofovir (CDV, HPMPC) for the treatment of peripheral CMV retinitis (CMV-R) in patients with AIDS. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:170

Reference Type BACKGROUND

Other Identifiers

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GS-93-106

Identifier Type: -

Identifier Source: secondary_id

216A

Identifier Type: -

Identifier Source: org_study_id