A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

N

Newport Pharmaceuticals

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Inosine pranobex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002059
ISO-133-USA
008E

Details and patient eligibility

About

The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to: Comparison of total helper and suppressor T-cell number between the groups. Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups. Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Opportunistic infections or Kaposi's sarcoma.
  • Critical illness.
  • History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Concurrent Medication:

Excluded:

  • Steroids.
  • Cytotoxic immunosuppressive agents.

Concurrent Treatment:

Excluded:

Radiotherapy.

The following are excluded:

  • Opportunistic infections or Kaposi's sarcoma.
  • Critically ill patients.
  • Patients receiving steroids, cytotoxic immunosuppressive agents, and/or 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 who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems