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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: |
NCT00000693 |
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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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Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS
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Scientific title:
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Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS |
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Date of first enrolment:
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July 2000 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00000693 |
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Study type:
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Interventional |
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Study design:
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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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CA Benson |
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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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HA Kessler |
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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
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.
Age minimum:
13 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cytomegalovirus Retinitis
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HIV Infections
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Intervention(s)
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Drug: Acyclovir
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Drug: Zidovudine
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Secondary ID(s)
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11044
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ACTG 070
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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