ClinicalTrials.gg
CompletedNCT00002297Updated Jun 24, 2005

A Study of Isoprinosine in Patients With Lymph Node Disease

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 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 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 and older · male · no healthy volunteers.

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02

Study summary

The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

  • Lymphadenopathy.
  • Fever.
  • Weight loss.
  • Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

  • T-helper cell (OKT4) numbers and proportions.
  • T-suppressor cell (OKT8) numbers and proportions.
  • Natural killer (NK) cell activity.
  • Lymphocyte blastogenic response to phytohemagglutinin (PHA).
  • Lymphocyte blastogenic response to pokeweed mitogen (PWM).
  • Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.
  • Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

  • Blood chemistry including serum uric acid (PurposeA-12).
  • Complete blood count (CBC).
  • Platelet count.
03

Conditions studied

  • Lymphatic Disease
  • HIV Infections

Keywords

  • Inosine Pranobex
  • 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 a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

  • Systemic .
  • Cytotoxic agents.
  • Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

  • Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).

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
NCT00002297
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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