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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

November 2, 1999
October 31, 2012
Not Provided
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Complete list of historical versions of study NCT00000799 on ClinicalTrials.gov Archive Site
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HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol
HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
  • Drug: Cidofovir
  • Drug: Probenecid
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 1996
Not Provided

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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000799
ACTG 281, GS-93-105, FDA 231A
Not Provided
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP