Status:

COMPLETED

A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Genentech, Inc.

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with ...

Detailed Description

Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the bu...

Eligibility Criteria

Inclusion Criteria

Patients must fulfill the following criteria:

  • Diagnosis of AIDS or AIDS-related complex, according to CDC criteria, in previously documented HIV seropositive individuals.
  • Failure to tolerate or respond to zidovudine (AZT) therapy for HIV infection or a decision to decline such therapy.
  • Willingness to abstain from all other experimental therapy for HIV infection during study period.
  • Life expectancy of at least 3 months.
  • Patients must be able to sign a written informed consent form.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Serious active opportunistic infection or malignancies not specifically allowed.

Concurrent Medication:

Excluded:

  • Oral or intravenous acyclovir for herpes.
  • Zidovudine (AZT).
  • Interferon.
  • Corticosteroids.
  • Nonsteroidal anti-inflammatory agents (NSAIDS).
  • Intravenous acyclovir.
  • Other known immunomodulatory agents.
  • Other experimental therapy.

Patients with the following are excluded:

  • Serious active opportunistic infection or malignancies not specifically allowed.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Zidovudine (AZT).
  • Chemotherapy.
  • Immunomodulatory agents.
  • Other experimental therapy.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00000675

Last Update

June 24 2005

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Stanford Univ School of Medicine

Stanford, California, United States, 94305

2

Univ of Washington

Seattle, Washington, United States, 98105