HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000799
First received: November 2, 1999
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cytomegalovirus Retinitis
HIV Infections
Drug: Cidofovir
Drug: Probenecid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 100
Study Completion Date: April 1996
Detailed Description:

In Stage 1, up to 30 patients are randomized to either observation with deferral of treatment until the retinitis progresses (observation group), or to intravenous HPMPC at the higher dose for two consecutive weekly induction doses, followed by the lower dose every other week for maintenance. In Stage 2, up to 70 patients are randomized to observation or to HPMPC at the higher dose for two consecutive weekly induction doses followed by either dose every other week for maintenance, for a total of three treatment groups. Concomitant saline hydration and probenecid are administered to patients receiving HPMPC.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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:

Allowed:

  • Prophylaxis with anti-CMV agents.

Exclusion Criteria

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.

  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: NCT00000799

Locations
United States, California
UCSD - Shiley Eye Ctr / SOCA
La Jolla, California, United States, 920930946
UCLA - Jules Stein Eye Institute / SOCA
Los Angeles, California, United States, 900957003
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94143
United States, Illinois
Northwestern Univ / SOCA
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins Hosp / SOCA
Baltimore, Maryland, United States, 212879217
United States, New York
New York Univ Med Ctr / SOCA
New York, New York, United States, 10016
United States, North Carolina
Univ of North Carolina / SOCA
Chapel Hill, North Carolina, United States, 275997030
Sponsors and Collaborators
Gilead Sciences
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000799     History of Changes
Other Study ID Numbers: ACTG 281, GS-93-105, FDA 231A
Study First Received: November 2, 1999
Last Updated: October 31, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Retinitis
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
cidofovir

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Retinitis
Cytomegalovirus Retinitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014