CMV Retinitis Retreatment Trial

This study has been completed.

Sponsor:

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00000766

First received: November 2, 1999

Last updated: February 28, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	February 28, 2011
Start Date ^ICMJE	Not Provided
Primary Completion Date	September 1995 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00000766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	CMV Retinitis Retreatment Trial
Official Title ^ICMJE	CMV Retinitis Retreatment Trial
Brief Summary	To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis. Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.
Detailed Description	Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs. Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	Cytomegalovirus Retinitis HIV Infections
Intervention ^ICMJE	Drug: Foscarnet sodium Drug: Ganciclovir
Study Arm (s)	Not Provided
Publications *	Jabs DA. Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial. Antiviral Res. 1996 Jan;29(1):69-71.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	Not Provided
Primary Completion Date	September 1995 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria Required: At least 28 days of prior foscarnet or ganciclovir. Concurrent Medication: Allowed: G-CSF. Recommended: Antiretroviral therapy. Patients must have: HIV infection or AIDS. Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy. At least one lesion with one-quarter disk area or more that can be photographed. Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Media opacity severe enough to preclude visualization of both fundi. Retinal detachment not scheduled for surgical repair. Patients with the following prior conditions are excluded: History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use. History of combination foscarnet/ganciclovir therapy. Active drug or alcohol abuse sufficient to prevent compliance.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00000766
Other Study ID Numbers ^ICMJE	ACTG 228
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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