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

Completed · Phase 1

Conditions studied: Immune Thrombocytopenic Purpura ( ITP ), HIV Infections

In brief

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.

Key facts

Study ID

NCT00002250

Run by

Genentech, Inc.

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• San Francisco Gen Hosp — San Francisco, California, United States

Full record on ClinicalTrials.gov

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