A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 1991
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (1)
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1991-08