A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

July 31, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Official Title ^ICMJE

A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Brief Summary

AMENDED: 04-12-91 Population of patients changed FROM those who are intolerant of systemic therapy with NON-sight-threatening CMV retinitis TO those AIDS patients intolerant of systemic therapy with CMV retinitis.

AMENDED: 8/8/90. Changes made in neutrophils count from < 500 to < 750 cells/mm3. Nonrandomized eyes will not be used for the primary efficacy evaluation.

ORIGINAL DESIGN: To determine the effectiveness and safety of ganciclovir (DHPG) therapy in AIDS patients suffering from active cytomegalovirus (CMV) infection of the retina of the eye (retinitis) when the drug is administered directly into the fluid-filled vitreous cavity of the eye by injection.

CMV retinitis is the most frequently seen opportunistic infection of the eye in AIDS patients, and left untreated can lead to severe visual loss and blindness. While systemic administration of DHPG has been shown to be an effective treatment for CMV retinitis, the chronic administration required may be complicated by decreased blood cell counts (granulocytopenia) which may require discontinuation of treatment. While withholding treatment may allow recovery from the granulocytopenia, interruption of therapy may result in reactivation of the retinitis. Injection of DHPG into the vitreous cavity of the eye may be of benefit to severely neutropenic patients with CMV retinitis.

Detailed Description

Patients must have active CMV retinitis in one or both eyes, despite prior systemic therapy. Following medical evaluation, the decision is made whether to treat the eye(s) immediately or to watch the eye(s) carefully for advancement of the retinitis. Eyes with sight-threatening lesions or eyes without functional vision are treated immediately and eyes without sight-threatening lesions are randomly chosen for either immediate or deferred therapy. DHPG is given by injection with a very fine needle twice a week for the first 3 weeks and once a week for the remaining 24 weeks.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label

Condition ^ICMJE

Cytomegalovirus Retinitis
HIV Infections

Intervention ^ICMJE

Drug: Ganciclovir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Concurrent Medication:

Allowed:

Zidovudine (AZT).
AMENDED: 8/8/90 Other available antiretroviral therapy.
Pneumocystis carinii pneumonia (PCP) prophylaxis, either systemic or local (aerosolized).
Chemotherapy for Kaposi's sarcoma.
Systemic therapy for intercurrent opportunistic infections.
Acyclovir or other treatment of Herpes simplex virus (HSV) or Varicella zoster virus (VZV) infections.
Systemic therapy deemed necessary for appropriate medical management.

Patients must have AIDS and cytomegalovirus (CMV) retinitis in at least one eye, diagnosed by an ophthalmologist and verified by fundoscopy and fundus photography.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.
Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.

Concurrent Medication:

Excluded:

Prophylactic acyclovir at time of study entry.
Other anticytomegalovirus (CMV) therapy, particularly systemic ganciclovir, foscarnet, or CMV hyperimmune globulin.
Topical ophthalmic medications should be avoided.
Cytomegalovirus (CMV) therapies and chronic acyclovir, including necessary therapies for an intercurrent opportunistic infection.

Patients with the following are excluded:

Contraindication to intravitreal injection, including obvious external infection and vitreous hemorrhage.
Medical opacities of cornea, lens, and/or vitreous which precludes fundus photography.

Gender

Both

Ages

13 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000673

Responsible Party

Study ID Numbers ^ICMJE

ACTG 085

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Polsky B

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 1994

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