HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

HIV Infections Clinical Trial

Official title:

HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000799
• Other study ID #: ACTG 281
• Secondary ID: GS-93-105FDA 231
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: October 31, 2012
• Est. completion date: April 1996

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Cidofovir

• Probenecid

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp / SOCA	Baltimore	Maryland
United States	Univ of North Carolina / SOCA	Chapel Hill	North Carolina
United States	Northwestern Univ / SOCA	Chicago	Illinois
United States	UCSD - Shiley Eye Ctr / SOCA	La Jolla	California
United States	UCLA - Jules Stein Eye Institute / SOCA	Los Angeles	California
United States	New York Univ Med Ctr / SOCA	New York	New York
United States	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Gilead Sciences

Country where clinical trial is conducted

United States, 

References & 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. — View Citation