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

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Genentech
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002004

Purpose

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).

Condition	Intervention	Phase
HIV Infections	Drug: CD4 Antigens	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment
Official Title:	A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002004

Locations

United States, California
Genentech Inc
South San Francisco, California, United States, 94080

Sponsors and Collaborators

Genentech

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00002004 History of Changes
Other Study ID Numbers:	064A, CO030g, Serial Number 002
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Recombinant Proteins
Acquired Immunodeficiency Syndrome
Antigens, CD4
AIDS-Related Complex

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 12, 2012