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HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

NCT ID: NCT00000799

Last Updated: 2012-11-01

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1996-04-30

Brief Summary

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To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.

Detailed Description

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In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Keywords

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Retinitis Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents cidofovir

Study Design

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Allocation Method

RANDOMIZED

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:

* Oral trimethoprim/sulfamethoxazole.
* Aerosolized pentamidine.
* Dapsone.
* Fluconazole.
* Ketoconazole.
* Itraconazole.
* Rifabutin.
* Filgrastim (G-CSF).
* Antiretroviral agents.

Patients must have:

* AIDS by CDC criteria.
* CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.

Prior Medication:

Allowed:

* Prophylaxis with anti-CMV agents.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
* Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Patients with the following prior conditions are excluded:

* History of renal disease or renal dialysis.
* History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* History of clinically significant probenecid allergy.

Prior Medication:

Excluded:

* Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
* Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.

Drug or alcohol abuse sufficient to hinder compliance with study.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Locations

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UCSD - Shiley Eye Ctr / SOCA

La Jolla, California, United States

Site Status

UCLA - Jules Stein Eye Institute / SOCA

Los Angeles, California, United States

Site Status

UCSF - San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Northwestern Univ / SOCA

Chicago, Illinois, United States

Site Status

Johns Hopkins Hosp / SOCA

Baltimore, Maryland, United States

Site Status

New York Univ Med Ctr / SOCA

New York, New York, United States

Site Status

Univ of North Carolina / SOCA

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.

Reference Type BACKGROUND
PMID: 9036798 (View on PubMed)

Other Identifiers

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GS-93-105

Identifier Type: -

Identifier Source: secondary_id

FDA 231A

Identifier Type: -

Identifier Source: secondary_id

ACTG 281

Identifier Type: -

Identifier Source: org_study_id