Status:
COMPLETED
A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Infections
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the clinical and laboratory toxicity of ganciclovir (GCV) and zidovudine (AZT) when given in combination. Because recent information has shown AZT to be useful in treating AIDS, it is ass...
Detailed Description
Because recent information has shown AZT to be useful in treating AIDS, it is assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is ...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Symptomatic therapy such as analgesics, antihistamines, antiemetics, and antidiarrheal agents, or other supportive therapy may be administered as deemed necessary by the responsible investigator. For fever, the following regimens should be used:
- If fever above 39.0 degrees C, antipyretic therapy will be administered employing aspirin, 650 mg orally every 4 hours x 3 doses, or until fever falls below 39.0 degrees C.
- If fever of higher than 39.0 degrees C occurs for 2 consecutive days, the patient may be premedicated with aspirin.
Exclusion Criteria
- Active alcohol or drug abuse.
Co-existing Condition:
Excluded:
- Patients with other life-threatening and uncontrolled opportunistic infections on enrollment.
Patients with the following prior conditions are excluded if they:
- Have other life-threatening and uncontrolled opportunistic infections on enrollment.
Prior Medication:
Excluded within 1 week of study entry:
- Systemic therapy with antimetabolite.
- Cytotoxic drug.
- Interferon.
- Immunologic modulators.
- Corticosteroids.
- Nucleoside analogs other than zidovudine (AZT).
- Excluded within 2 weeks of study entry:
- Therapy for any other opportunistic infections.
- Excluded within 2 months of study entry:
- Ribavirin.
Prior Treatment:
Excluded within 2 weeks of study entry (for treatment group I):
- Blood transfusion.
- Excluded within 1 month of study entry (for treatment groups II and III):
- Blood transfusion.
All patients must be:
- Able to provide informed consent.
- Likely to be available for follow-up for at least 4 months.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
February 1 1990
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000995
End Date
February 1 1990
Last Update
November 4 2021
Active Locations (3)
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1
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
2
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
3
Univ of Rochester Medical Center
Rochester, New York, United States, 14642