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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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002005 on ClinicalTrials.gov Archive Site
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A Phase I Study of Recombinant CD4(rCD4) in Patients With AIDS and AIDS-Related Complex
A Phase I Study 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 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.

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Interventional
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Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
Drug: CD4 Antigens
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002005
064B, CO036g, Serial Number 002
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Genentech, Inc.
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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