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Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals



Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia and Upjohn ,
Synopsis: To investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( sCD4-PE40; soluble CD4-Pseudomonas exotoxin ) at a fixed dose when administered to HIV-1-infected individuals. To investigate the effect of sCD4-PE40 on the following parameters: T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - HIV positivity confirmed by Western blot. - CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma. - Hemophilia or other clotting disorders. - Major organ allograft. - Significant cardiac, hepatic, renal, or CNS disease. Prior Medication: Excluded: - Antiretroviral agents within 2 months prior to study entry. - Known anti-HIV medication within 60 days prior to study entry. - Prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy. Prior Treatment: Excluded: - Prior radiation therapy. Active substance abuse.
Total Enrollment: 

Location and Contact Information:

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 


Additional Information:
Study ID Numbers:
  084A;  Amend 022,P/3325/0002
Study Start Date: 
Record last reviewed: April 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002087

Other Hiv Infections Studies:
1. Phase I Study of Alferon N Injection in Persons With Asymptomatic Human Immunodeficiency Virus (HIV) Infection

2. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV

3. A Study to Evaluate the Impact of Stopping Treatment for the Prevention of Pneumonia in HIV-Positive Patients Receiving Anti-HIV Drugs Who Have Increased CD4 Cell Counts

4. Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC

5. Growth Hormone Treatment of Children with HIV-Associated Growth Failure

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Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals

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