The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

N

Newport Pharmaceuticals

Status

Completed

Conditions

Lymphatic Disease
HIV Infections

Treatments

Drug: Inosine pranobex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002296
ISO-106-USA
008C

Details and patient eligibility

About

The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters: Increase in natural killer (NK) cell activity. Increase in total T-cells (OKT-11). Increases in absolute number and percentage of T-helper cells (OKT-4).

Sex

Male

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
  • Lymphoid malignancy.
  • Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
  • Heart disease (especially if receiving cardiac glycosides).
  • Hemophilia.

Patients with the following are excluded:

Kaposi's sarcoma or overt opportunistic infections as follows:

  • Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
  • Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
  • History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
  • Critical illness.
  • Condition requiring hospitalization.
  • Women of childbearing age are excluded.
  • Hemophilia.

Prior Medication:

Excluded:

  • Steroids.
  • Cytotoxic immunosuppressive agents.
  • Antiviral medicine.

Prior Treatment:

Excluded:

Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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