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A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex



A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex

For Condition: HIV Infections
Status: Completed
Sponsor(s): Genentech ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Genentech Inc
San Francisco,  California,  94080
United States
 


Additional Information:
Study ID Numbers:  064B;  CO036g,Serial Number 002
Study Start Date: 
Record last reviewed: January 1990
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002005

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