Clinical trial NCT00002250: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune Thrombocytopenic Purpura ( ITP )
HIV Infections
Keywords: Recombinant Proteins
IgG
Drug Evaluation
Antigens, CD4
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Gen Hosp
state: California
Study officials:
References:
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)