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A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
This study has been completed.
Study NCT00002250   Information provided by NIH AIDS Clinical Trials Information Service
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00002250 on ClinicalTrials.gov Archive Site
 
 
 
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura

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 I
Interventional
Treatment, Dose Comparison
  • Immune Thrombocytopenic Purpura ( ITP )
  • HIV Infections
Drug: CD4-IgG
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002250
 
076A, D0177g
Genentech
 
 
NIH AIDS Clinical Trials Information Service
August 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP