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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.
Sponsored by: Genentech
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002250
  Purpose

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.


Condition Intervention Phase
Immune Thrombocytopenic Purpura ( ITP )
HIV Infections
Drug: CD4-IgG
Phase I

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura
MedlinePlus related topics: AIDS
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Dose Comparison
Official Title: A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002250

Locations
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Sponsors and Collaborators
Genentech
  More Information

Publications:
Kahn J, Hassner A, Arri C, Coleman R, Kaplan L, Volberding P, Ammann A, Abrams D. A phase 1 study of recombinant human CD4 immunoglobulin g (rCD4-IgG) in patients with HIV-associated immune thrombocytopenic purpura. Int Conf AIDS. 1991 Jun 16-21;7(2):221 (abstract no WB2156)

Study ID Numbers: 076A, D0177g
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002250  
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Recombinant Proteins
IgG
Drug Evaluation
Antigens, CD4

Study placed in the following topic categories:
Purpura
Sexually Transmitted Diseases, Viral
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Acquired Immunodeficiency Syndrome
Hemostatic Disorders
Purpura, Thrombocytopenic
Immunologic Deficiency Syndromes
Virus Diseases
Thrombocytopathy
Signs and Symptoms
Antibodies
Thrombocytopenia
HIV Infections
Sexually Transmitted Diseases
Immunoglobulin G
CD4 Immunoadhesins
Retroviridae Infections
Immunoglobulins

Additional relevant MeSH terms:
Skin Manifestations
RNA Virus Infections
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009