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

Primary Purpose

Immune Thrombocytopenic Purpura ( ITP ), HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CD4-IgG
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenic Purpura ( ITP ) focused on measuring Recombinant Proteins, IgG, Drug Evaluation, Antigens, CD4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Gen Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00002250
Brief Title
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
Official Title
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
August 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura ( ITP ), HIV Infections
Keywords
Recombinant Proteins, IgG, Drug Evaluation, Antigens, CD4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CD4-IgG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States

12. IPD Sharing Statement

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

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