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

• Status: Completed
• Trial end date: 1990-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Ganciclovir; Ganciclovir triphosphate; Zidovudine

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.