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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00000995 |
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Date of registration:
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02/11/1999 |
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Primary sponsor: |
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Public title:
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A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection
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Scientific title:
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Phase I Studies of the Combination of AZT and DHPG (Ganciclovir) in Patients With AIDS and Cytomegalovirus Infection |
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Date of first enrolment:
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November 1999 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000995 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Hochster H |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Reichman RC |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Richman D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cytomegalovirus Infections
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HIV Infections
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Intervention(s)
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Drug: Ganciclovir
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Drug: Zidovudine
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Secondary ID(s)
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10980
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ACTG 004
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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