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

Genentech

Status and phase: Completed; Phase 1

Conditions: Immune Thrombocytopenic Purpura ( ITP ); HIV Infections

Treatments: Drug: CD4-IgG

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002250

076A

D0177g

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.