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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-27
38
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 2 locations
1
Univ. of Miami AIDS CRS
Miami, Florida, United States, 33136
Status Unknown
2
Washington U CRS
St Louis, Missouri, United States
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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