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

P

Pharmacia & Upjohn

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Alvircept sudotox

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002087
Amend 022
084A
P/3325/0002

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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