An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis. To determine the time to retinitis progression in this patient population. To evaluate the impact of cidofovir therapy on visual acuity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients are randomized to receive intravenous HPMPC either at one dose for both induction and maintenance or at a higher dose for induction than for maintenance. Induction consists of two consecutive weekly doses followed by maintenance every other week. All patients receive concomitant probenecid and saline hydration. Treatment continues until retinitis progression, as assessed by retinal photographs, or treatment-limiting toxicity occurs.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cytomegalovirus Retinitis HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cidofovir

Intervention Type DRUG

Probenecid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Concurrent Medication:

Allowed:

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

Patients must have:

* AIDS.
* CMV retinitis, with severity as specified in the Disease Status field.
* Life expectancy of at least 3 months.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known clinically significant allergy to probenecid.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Other active medical problems sufficient to hinder study compliance.

Concurrent Medication:

Excluded:

* Amphotericin B.
* Aminoglycoside antibiotics.
* Vidarabine.
* Intravenous pentamidine.
* CMV hyperimmune immunoglobulin.
* Other nephrotoxic or potentially nephrotoxic agents.
* Other investigational agents with anti-CMV activity.
* Ganciclovir.
* Intravenous or oral acyclovir (except following development of herpetic lesion).
* Foscarnet.
* Diuretics.

Prior Medication:

Excluded within 2 days prior to study entry:

* Ganciclovir or foscarnet.

Excluded within one week prior to study entry:

* Amphotericin B.
* Aminoglycoside antibiotics.
* Vidarabine.
* Intravenous pentamidine.
* CMV hyperimmune immunoglobulin.
* Other nephrotoxic agents.
* Other investigational agents with anti-CMV activity.

Excluded at any time:

Prior systemic or intravitreal HPMPC.

Drug or alcohol abuse that is considered sufficient to hinder study compliance.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Besselaar Associates

Princeton, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Stagg RJ, et al. The Vistide (cidofovir injection) treatment IND for relapsing CMV retinitis (CMV-R). 4th Conf Retro and Opportun Infect. 1997 Jan 22-26;:120 (abstract no 306)

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GS-93-107

Identifier Type: -

Identifier Source: secondary_id

216B