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CMV Retinitis Retreatment Trial

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cytomegalovirus Retinitis; HIV Infections

Intervention: Foscarnet sodium (Drug); Ganciclovir (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Clinical Details

Official title: CMV Retinitis Retreatment Trial

Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

Mount Sinai Med Ctr / SOCA, New York, New York 100296574, United States

New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA, New York, New York 10021, 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

Additional Information

Related 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.


Last updated: February 28, 2011

Page last updated: August 20, 2015

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