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 - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000673

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cytomegalovirus Infections

Drug Information available for: Ganciclovir Ganciclovir sodium

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

38

Detailed Description:

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.

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.

Eligibility

Ages Eligible for Study:	13 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000673

Locations

United States, California
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Illinois
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States, 01199
United States, New York
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:

Polsky B

More Information

Additional Information:

Click here for more information about Ganciclovir This link exits the ClinicalTrials.gov site

Publications:

Polsky B, Wolitz R, Cantrill H, Chuang EL, Heinemann MH, Sands M, Feinberg JE, Power M, Davis R. Intravitreal (IVL) Ganciclovir (GCV) salvage therapy (Rx) for cytomegalovirus (CMV) retinitis (ACTG 085): a preliminary report. Int Conf AIDS. 1991 Jun 16-21;7(2):267 (abstract no WB2340)

Polsky, et al. Intravitreal ganciclovir salvage therapy for cytomegalovirus retinitis in AIDS: AIDS Clinical Trials Groups Protocol 085. Int J Infect Dis. 1996 Oct; 1(2):70-4

Study ID Numbers:	ACTG 085
Study First Received:	November 2, 1999
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00000673 History of Changes
Health Authority:	United States: Federal Government

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

Retinitis
AIDS-Related Opportunistic Infections
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:

Opportunistic Infections
Sexually Transmitted Diseases, Viral
Eye Diseases
Eye Infections
Acquired Immunodeficiency Syndrome
Cytomegalovirus Retinitis
Retinitis
Ganciclovir
Antiviral Agents
Cytomegalovirus
Immunologic Deficiency Syndromes

Herpesviridae Infections
Virus Diseases
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Cytomegalic Inclusion Disease
Cytomegalovirus Infections
DNA Virus Infections
Retroviridae Infections
Retinal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Retinitis
Infection
Therapeutic Uses
Cytomegalovirus Infections
Retroviridae Infections
Retinal Diseases
RNA Virus Infections
Immune System Diseases
Eye Infections, Viral
Eye Diseases

Cytomegalovirus Retinitis
Acquired Immunodeficiency Syndrome
Eye Infections
Ganciclovir
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 02, 2009