Status:
COMPLETED
A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with ...
Detailed Description
Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the bu...
Eligibility Criteria
Inclusion Criteria
Patients must fulfill the following criteria:
- Diagnosis of AIDS or AIDS-related complex, according to CDC criteria, in previously documented HIV seropositive individuals.
- Failure to tolerate or respond to zidovudine (AZT) therapy for HIV infection or a decision to decline such therapy.
- Willingness to abstain from all other experimental therapy for HIV infection during study period.
- Life expectancy of at least 3 months.
- Patients must be able to sign a written informed consent form.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Serious active opportunistic infection or malignancies not specifically allowed.
Concurrent Medication:
Excluded:
- Oral or intravenous acyclovir for herpes.
- Zidovudine (AZT).
- Interferon.
- Corticosteroids.
- Nonsteroidal anti-inflammatory agents (NSAIDS).
- Intravenous acyclovir.
- Other known immunomodulatory agents.
- Other experimental therapy.
Patients with the following are excluded:
- Serious active opportunistic infection or malignancies not specifically allowed.
Prior Medication:
Excluded within 4 weeks of study entry:
- Zidovudine (AZT).
- Chemotherapy.
- Immunomodulatory agents.
- Other experimental therapy.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00000675
Last Update
June 24 2005
Active Locations (2)
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1
Stanford Univ School of Medicine
Stanford, California, United States, 94305
2
Univ of Washington
Seattle, Washington, United States, 98105