ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002004
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

November 2, 1999
August 31, 2001
June 24, 2005
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
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).
Not Provided
Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
Drug: CD4 Antigens
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002004
064A
CO030g
Serial Number 002
Not Provided
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
January 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP