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A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura

This study has been completed.
Study NCT00002250.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
Official Title  A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
Brief Summary

To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Dose Comparison
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Immune Thrombocytopenic Purpura ( ITP )
HIV Infections
Intervention  Drug: CD4-IgG
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
  • Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.

Patients must have the following:

  • HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).
  • HIV-associated immune thrombocytopenic purpura.
  • The ability to sign a written informed consent form, which must be obtained prior to treatment.
  • A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
  • Patients currently on zidovudine are not excluded. However, the zidovudine dose level must remain constant for 4 weeks prior to entry and for the 12 weeks of treatment, except if zidovudine related toxicity is observed.
  • A life expectancy of at least 3 months.

Prior Medication:

Allowed:

  • Dapsone at a constant dose for more than 2 weeks prior to study entry.
  • Zidovudine at a constant dose for 4 weeks prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

  • Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
  • Malignancies other than Kaposi's sarcoma.
  • Tumor-associated edema.
  • Visceral Kaposi's sarcoma.
  • Significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

  • Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.

Patients with the following are excluded:

  • Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
  • Malignancies other than Kaposi's sarcoma.
  • Kaposi's sarcoma requiring therapy.
  • Tumor-associated edema.
  • Visceral Kaposi's sarcoma.
  • Significant neurologic, cardiac, or liver disease.
  • Conditions requiring excluded concomitant medications.
  • Herpes virus infection requiring intravenous acyclovir.

Prior Medication:

Excluded for a minimum of 4 weeks prior to study entry:

  • Chemotherapy.
  • Immunomodulatory agents.
  • Any experimental therapy.

Prior Treatment:

Excluded for a minimum of 4 weeks prior to study entry:

  • Radiation therapy.
  • Any experimental therapy.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002250
Organization ID 076A
Secondary IDs †† D0177g
Study Sponsor  Genentech
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date August 1991
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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