The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS
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
2 other identifiers
interventional
48
2 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1994
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (9)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCI Med Ctr
Orange, California, 92668, United States
Mount Zion Med Ctr
San Francisco, California, 94115, United States
Beth Israel Hosp
Boston, Massachusetts, 02215, United States
Besselaar Associates
Princeton, New Jersey, 085406681, United States
Univ of Rochester Med Ctr
Rochester, New York, 14607, United States
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599, United States
Audie L Murphy Veterans Administration Hosp
San Antonio, Texas, 78284, United States
Charing Cross and Westminster Med School
London Southwest 10, United Kingdom
Related Publications (1)
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
BACKGROUND