HIV Infections Clinical Trial
Official title:
A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
NCT number | NCT00002005 |
Other study ID # | 064B |
Secondary ID | CO036gSerial Num |
Status | Completed |
Phase | N/A |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and ARC. To measure steady state serum levels of rCD4 following continuous infusion therapy.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria Patients must have: - 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 Co-existing Condition: 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. |
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Genentech Inc | South San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Genentech, Inc. |
United States,
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