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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Antibodies; CD4 Immunoadhesins; Immunoglobulin G; Immunoglobulins

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.