ClinicalTrials.gg
CompletedNCT00002061Updated Jun 24, 2005

A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

An interventional study of Inosine pranobex in Lymphatic Disease and HIV Infections, sponsored by Newport Pharmaceuticals International. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years. 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 to 50 Years
Sex
Male
01

Where this study stands

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

Among 53 studies in Lymphatic Diseases with a site in United States — 8 open to participants now, 17 under way, 1 of them phase 3. Lymphatic Diseases · United States.

No phase
7 of 53
1 open now
Registered
1st of 53
by date
Lead sponsor
3 of 53
Newport Pharmaceuticals International

Among the 53 studies in Lymphatic Diseases with a site in United States, this one is one of 7 with no phase, and was the 1st registered.

Lymphatic Diseases

83 studies on the registry are indexed under Lymphatic Diseases; 12 are open to participants now.

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Open to participants now

8 of the 53 studies in Lymphatic Diseases with a site in United States are open now. Recruiting first, the newest first:

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All 8 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 9 Lymphatic Diseases studies recruiting now, 6 set no upper age limit and none stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years to 50 Years · male · no healthy volunteers.

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02

Study summary

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 immunologic parameters:

  • Increase in natural killer (NK) cell activity.
  • Increase in total T-cells (OKT-11).
  • Increases in absolute number and percentages of T-helper cells (OKT-4).
03

Conditions studied

  • Lymphatic Disease
  • HIV Infections

Keywords

  • T-Lymphocytes
  • Immune Tolerance
  • Inosine Pranobex
  • Killer Cells
  • T-Lymphocytes, Helper-Inducer
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility 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 .
  • Infectious mononucleosis caused by cytomegalovirus (CMV) or Epstein-Barr virus (EBV).
  • Heart disease (especially if receiving cardiac glycosides).
  • Hemophilia.

Patients with the following are excluded:

  • Kaposi's sarcoma or overt opportunistic infections.
  • Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophile test (EBV) or cell culture (CMV).
  • A 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.

Prior Medication:

Excluded:

  • , cytotoxic agents.
  • Antiviral medicine.
  • Excluded within 1 month of study entry:
  • Immunomodulators (including Isoprinosine).

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.

Terms in these criteria, in plain language(3)

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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
NCT00002061
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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