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

NCT ID: NCT00002250

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

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.

Conditions

Immune Thrombocytopenic Purpura ( ITP ); HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

CD4-IgG

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Locations

San Francisco Gen Hosp

San Francisco, California, United States

Countries

United States

References

Kahn J, Hassner A, Arri C, Coleman R, Kaplan L, Volberding P, Ammann A, Abrams D. A phase 1 study of recombinant human CD4 immunoglobulin g (rCD4-IgG) in patients with HIV-associated immune thrombocytopenic purpura. Int Conf AIDS. 1991 Jun 16-21;7(2):221 (abstract no WB2156)

Reference Type: BACKGROUND

Other Identifiers

D0177g

Identifier Type: -

Identifier Source: secondary_id

076A

Identifier Type: -

Identifier Source: org_study_id