- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002437
The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
June 23, 2005 updated by: Gilead Sciences
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London SW 10, United Kingdom
- Charing Cross and Westminster Med School
-
-
-
-
California
-
Los Angeles, California, United States, 90033
- Los Angeles County - USC Med Ctr
-
Orange, California, United States, 92668
- UCI Med Ctr
-
San Francisco, California, United States, 94115
- Mount Zion Med Ctr
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Hosp
-
-
New Jersey
-
Princeton, New Jersey, United States, 085406681
- Besselaar Associates
-
-
New York
-
Rochester, New York, United States, 14607
- Univ of Rochester Med Ctr
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Univ of North Carolina Hosps
-
-
Texas
-
San Antonio, Texas, United States, 78284
- Audie L Murphy Veterans Administration Hosp
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 1994
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Virus Diseases
- Infections
- Eye Diseases
- Retinal Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Eye Infections
- Eye Infections, Viral
- Cytomegalovirus Infections
- Retinitis
- Cytomegalovirus Retinitis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Gout Suppressants
- Renal Agents
- Uricosuric Agents
- Cidofovir
- Probenecid
Other Study ID Numbers
- 216A
- GS-93-106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Probenecid
-
University of MiamiUnited States Department of DefenseRecruitingInfertility, MaleUnited States
-
University of Maryland, BaltimoreNational Institutes of Health (NIH); National Institute of General Medical...Completed
-
VA Office of Research and DevelopmentRecruiting
-
Iterum Therapeutics, International LimitedAvailableAcute Pyelonephritis | Complicated Urinary Tract Infection
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
TrippBio, Inc.Completed
-
Atea Pharmaceuticals, Inc.RecruitingRenal Impairment | Healthy VolunteerCanada
-
University of CincinnatiCompletedSystolic Heart FailureUnited States
-
TrippBio, Inc.Not yet recruitingRelative Bioavailability
-
Kelowna General HospitalCapital Health, Canada; Canadian Society of Hospital Pharmacists; Interior Health...Completed