A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection

Completed · Not applicable

Conditions studied: Cytomegalovirus Infections, HIV Infections

In brief

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 assumed that most patients with AIDS, and probably with AIDS related complex (ARC), will be receiving AZT. Because AZT is reported not to be active against cytomegalovirus (CMV), it is important to see if it is useful to give GCV along with AZT.

Key facts

Study ID

NCT00000995

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Expected to finish

1990-02-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Univ of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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