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CompletedNCT00002059Updated Jun 24, 2005

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

An interventional study of Inosine pranobex in HIV Infections, sponsored by Newport Pharmaceuticals International. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Newport Pharmaceuticals International · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,802 studies in HIV Infections with a site in United States — 83 open to participants now, 140 under way, 11 of them phase 3. HIV Infections · United States.

No phase
718 of 2,802
42 open now
Registered
4th of 2,802
by date

Among the 2,802 studies in HIV Infections with a site in United States, this one is one of 718 with no phase, and was the 4th registered.

HIV Infections

4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.

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Open to participants now

83 of the 2,802 studies in HIV Infections with a site in United States are open now. Recruiting first, the newest first:

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All 83 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 158 HIV Infections studies recruiting now, 104 (66%) set no upper age limit and 41 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

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02

Study summary

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.
03

Conditions studied

  • HIV Infections

Keywords

  • T-Lymphocytes, Suppressor-Effector
  • Neoplasms
  • Inosine Pranobex
  • Killer Cells
  • T-Lymphocytes, Helper-Inducer
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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:

  • .
  • Cytotoxic 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double

Interventions

06

Study locations

1 site
  • Newport Pharmaceuticals International Inc
    Laguna Hills, California 92656, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002059
Lead sponsor
Newport Pharmaceuticals International
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 1989. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Inosine Pranobex

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