Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis - Full Text View

Purpose

OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis.

II. Obtain safety and efficacy data related to different dosages of cidofovir.

Condition	Intervention	Phase
Cytomegalovirus Retinitis Acquired Immunodeficiency Syndrome	Drug: cidofovir	Phase 2


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Cidofovir

Genetic and Rare Diseases Information Center resources: Cytomegalovirus Retinitis Cytomegalic Inclusion Disease

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):


Estimated Enrollment:	90
Study Start Date:	March 1995

Detailed Description:

PROTOCOL OUTLINE: This is a randomized study. Cidofovir is administered intravenously. Treatment ideally begins within 24 hours of randomization.

In the first group, therapy is deferred until disease progression. Patients are then treated according to best medical judgement, which includes the option of cidofovir therapy.

The second group receives induction with cidofovir every 7 days for 2 weeks, then begins maintenance with a low dose given every 14 days until dose-limiting toxicity or disease progression occurs.

The third group receives the same cidofovir induction followed by a high maintenance dose given every 14 days until dose-limiting toxicity or disease progression occurs.

Probenecid and intravenous hydration are administered concurrently with cidofovir.

Patients are followed for progression and survival every 2 weeks for 23 weeks, then every 12 weeks. At disease progression, patients may be re-treated with another course of induction and maintenance.

Eligibility


Ages Eligible for Study:	13 Years to 60 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Acquired immunodeficiency syndrome (AIDS) Meets Centers for Disease Control and Prevention definition
Peripheral cytomegalovirus (CMV) retinitis Diagnosed by ophthalmologist certified by the Study of Ocular Complications of AIDS group At least 1 lesion measuring at least 25% of disc on photograph No lesion within zone 1 No lesion involving 25% or more of retina regardless of location
Visual acuity in affected eye 3 or more lines on the Early Treatment Diabetic Retinopathy Study chart at 1 meter Snellen equivalent 8/200
No retinal detachment in affected eye
No media opacity that precludes visualization of fundus in both eyes
No extraocular CMV disease

--Prior/Concurrent Therapy--

No prior or concurrent anti-CMV therapy, i.e.: Ganciclovir Foscarnet CMV hyperimmune immunoglobulin Other investigational agents with anti-CMV activity
Prior CMV prophylaxis allowed
At least 7 days since nephrotoxic drugs, including: Amphotericin B Vidarabine Aminoglycoside antibiotics Intravenous pentamidine

--Patient Characteristics--

Age: 13 to 60
Performance status: Karnofsky 60%-100%
Hematopoietic: ANC at least 750 Platelets at least 50,000 Hemoglobin greater than 7.5 g/dL
Hepatic: Bilirubin no greater than 3.0 mg/dL Transaminases no greater than 5 times normal
Renal: Creatinine no greater than 1.5 mg/dL Proteinuria less than 1+ No clinically significant renal disease No dialysis
Cardiovascular: No clinically significant cardiac disease, including: Ischemia Congestive heart failure Arrhythmia
Other:

No probenecid allergy No medical problems sufficient to hinder compliance with therapy or follow- up, including drug or alcohol abuse No pregnant or nursing women Negative serum pregnancy test required of fertile women Adequate birth control required of fertile patients during and for 3 months after study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004794

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Northwestern University

Investigators


Study Chair:	David V. Weinberg	Northwestern University

More Information


ClinicalTrials.gov Identifier:	NCT00004794 History of Changes
Other Study ID Numbers:	199/11927 NU-506
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):


cytomegalovirus retinitis ophthalmologic disorders rare disease

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Retinitis Cytomegalovirus Retinitis Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Slow Virus Diseases Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Cidofovir Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on June 23, 2017