CMV Retinitis Retreatment Trial

HIV Infections Clinical Trial

Official title:

CMV Retinitis Retreatment Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000766
• Other study ID #: ACTG 228
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: February 28, 2011

Study information

• Verified date: February 2011
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. primary completion date: September 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Foscarnet sodium

• Ganciclovir

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	Mount Sinai Med Ctr / SOCA	New York	New York
United States	New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA	New York	New York
United States	New York Univ Med Ctr / SOCA	New York	New York
United States	UCSF - San Francisco Gen Hosp	San Francisco	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

External Links

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