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

Study Overview
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Brief Summary
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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.

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

Conditions
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Immune Thrombocytopenic Purpura ( ITP ), HIV Infections

Intervention / Treatment
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* Drug: CD4-IgG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CD4-IgG|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IgG, Recombinant Proteins, Drug Evaluation, Antigens, CD4