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A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome


N/A
18 Years
N/A
Not Enrolling
Both
HIV Infections

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Trial Information

A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Inclusion Criteria


Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and
severe gastric ulcer are excluded.

Concurrent Medication:

Excluded:

- Steroids.

- Cytotoxic immunosuppressive agents.

- Radiotherapy.

The following are excluded:

- Critically ill patients.

- Patients receiving steroids, cytotoxic immunosuppressive agents, radiotherapy.

- Patients who have received any other immunotherapy.

- Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction,
and severe gastric ulcer.

Prior Medication:

Excluded:

- Any other immunotherapy.

Patients with severe AIDS and specified laboratory immunologic defects.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

008F

NCT ID:

NCT00002295

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Infusions, Intravenous
  • Drug Evaluation
  • Administration, Oral
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • Biological Availability
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Immunologic Deficiency Syndromes

Name

Location

Newport Pharmaceuticals International IncLaguna Hills, California  92656