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

Launched by GENENTECH, INC. · Aug 30, 2001

Keywords

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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.