A Study of Isoprinosine in Patients With Severe AIDS

N

Newport Pharmaceuticals

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Inosine pranobex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002295
ISO-141-USA
008F

Details and patient eligibility

About

To evaluate the effect of Isoprinosine in patients diagnosed as having AIDS relative to: Laboratory (immunologic defects): * Comparison of total helper and suppressor T-cell numbers among the groups. * Comparison of changes in natural killer cell activity. * Comparison of other laboratory findings among the groups. Clinical changes: * Comparison of the frequency of opportunistic infections among the groups. * Comparison of the frequency of the development of AIDS-related malignancies. * Comparison of other clinical manifestations relative to severity and time of onset.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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