A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
NCT ID: NCT00002004
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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CD4 Antigens
Eligibility Criteria
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Inclusion Criteria
* HIV-1 seropositivity.
* Diagnosis of AIDS or AIDS related complex (ARC).
* Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
* The ability to sign a written informed consent form prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* A life expectancy of at least 3 months.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.
Concurrent Medication:
Excluded:
* Zidovudine (AZT).
* Corticosteroids.
* Nonsteroidal anti-inflammatory agents (NSAI).
* Other experimental therapy.
Patients with the following are excluded:
* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.
Prior Medication:
Excluded within 3 weeks of study entry:
* Zidovudine (AZT).
* Chemotherapy.
* Immunomodulators.
* Other experimental therapy.
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Locations
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Genentech Inc
South San Francisco, California, United States
Countries
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Other Identifiers
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CO030g
Identifier Type: -
Identifier Source: secondary_id
Serial Number 002
Identifier Type: -
Identifier Source: secondary_id
064A
Identifier Type: -
Identifier Source: org_study_id