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

This study has been completed.

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00002005

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: January 1990

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00002005 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
Official Title ^ICMJE	A Phase I Study 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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: CD4 Antigens
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
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 Number ^ICMJE	NCT00002005
Other Study ID Numbers ^ICMJE	064B, CO036g, Serial Number 002
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Genentech
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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