Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13-65 years
Phase:
PHASE1
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 C...
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 ha...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
May 1 1993
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00000673
End Date
May 1 1993
Last Update
October 27 2021
Active Locations (2)
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1
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
2
Washington U CRS
St Louis, Missouri, United States