A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002004 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
Official Title ^ICMJE	A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
Brief Summary	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 assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Pharmacokinetics Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: CD4 Antigens
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002004
Responsible Party
Study ID Numbers ^ICMJE	064A, CO030g, Serial Number 002
Study Sponsor ^ICMJE	Genentech
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	January 1990
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP