HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
3 other identifiers
interventional
100
1 country
7
Brief Summary
To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions. To provide data on the relative safety and efficacy of 2 doses of HPMPC as maintenance regimens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
7 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
Study Completion
Last participant's last visit for all outcomes
April 1, 1996
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2012
October 1, 2012
November 2, 1999
October 31, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Oral trimethoprim/sulfamethoxazole.
- Aerosolized pentamidine.
- Dapsone.
- Fluconazole.
- Ketoconazole.
- Itraconazole.
- Rifabutin.
- Filgrastim (G-CSF).
- Antiretroviral agents.
- Patients must have:
- AIDS by CDC criteria.
- CMV retinitis as determined by a SOCA-certified ophthalmologist, with lesion size, location, and severity as specified in the Disease Status field.
- Prior Medication:
- +2 more criteria
You may not qualify if:
- Concurrent Medication:
- Excluded:
- Ongoing therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
- Therapy with nephrotoxic drugs, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.
- Patients with the following prior conditions are excluded:
- History of renal disease or renal dialysis.
- History of clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
- History of clinically significant probenecid allergy.
- Prior Medication:
- Excluded:
- Prior therapy for CMV disease with ganciclovir, foscarnet, CMV hyperimmune immunoglobulin, or other investigational agents with anti-CMV activity.
- Therapy with nephrotoxic drugs within the past 7 days, including amphotericin B, aminoglycoside antibiotics, vidarabine, and intravenous pentamidine.
- Drug or alcohol abuse sufficient to hinder compliance with study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, 920930946, United States
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, 900957003, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94143, United States
Northwestern Univ / SOCA
Chicago, Illinois, 60611, United States
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, 212879217, United States
New York Univ Med Ctr / SOCA
New York, New York, 10016, United States
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, 275997030, United States
Related Publications (1)
Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: the HPMPC peripheral cytomegalovirus retinitis trial. A randomized, controlled trial. Studies of Ocular complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Ann Intern Med. 1997 Feb 15;126(4):264-74. doi: 10.7326/0003-4819-126-4-199702150-00002.
PMID: 9036798BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
April 1, 1996
Last Updated
November 1, 2012
Record last verified: 2012-10