HIV Infections, Immune Thrombocytopenic Purpura ( ITP )
Conditions
Keywords
Recombinant Proteins, IgG, Drug Evaluation, Antigens, CD4
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.
Interventions
DRUGCD4-IgG
Sponsors
Genentech, Inc.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed