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

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