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
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of January 15, 2025
Completed
Keywords
ClinConnect Summary
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 cavi...
Gender
ALL
Eligibility 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.
Trial Officials
Polsky B
Study Chair
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Saint Louis, Missouri, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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