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

NCT00002142 | Completed

• 2 other identifiers: 216BGS-93-107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Keywords

Retinitis; Probenecid; Drug Therapy, Combination; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome; Antiviral Agents; cidofovir

Interventions

Cidofovir DRUG

Probenecid DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Besselaar Associates

Princeton, New Jersey, 085406681, United States

Location

Related Publications (1)

• 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)

  BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Retinitis; HIV Infections; Retinitis; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome

Interventions

Cidofovir; Probenecid

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinal Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1995-10

Locations

US (1)