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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002250
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1991
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
  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)

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

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Signs and Symptoms
Skin Manifestations
Slow Virus Diseases
Thrombocytopenia
Thrombotic Microangiopathies
Virus Diseases
Antibodies
Immunoglobulin G
Immunoglobulins
Immunologic Factors
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014