Status:
COMPLETED
Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
To study the use of acyclovir (ACV) and zidovudine (AZT) in the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS who would otherwise be treated with ganciclovir (DHPG) alone. CMV re...
Detailed Description
CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most ...
Eligibility Criteria
Inclusion Criteria
Prior Medication:
Required:
- Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction.
Amended to allow:
- Investigational triazoles.
- Human recombinant erythropoietin (Eprex).
- Other investigational non-antiviral therapies offered through treatment IND.
Patients must:
- Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot
- Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye.
- Be capable of signing an informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Known or suspected allergy to one of the study medications.
- Inability to maintain adequate hydration status.
Concurrent Medication:
Excluded:
- Concurrent therapy with nephrotoxic agents.
- Systemic therapy for another opportunistic infection.
- Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Probenecid.
- Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments.
Patients with the following are excluded:
- Known or suspected allergy to one of the study medications.
- Inability to maintain adequate hydration status.
Prior Medication:
Excluded within 2 weeks of study entry:
- Steroids.
- Cytotoxic or immunosuppressive drugs.
- Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir).
Prior Treatment:
Excluded within 2 weeks of study entry:
- Radiotherapy.
Risk Behavior:
Excluded:
- History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1992
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00000693
End Date
March 1 1992
Last Update
November 2 2021
Active Locations (2)
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1
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
2
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612