ClinicalTrials.gg
CompletedNCT00002295Updated Jun 24, 2005

A Study of Isoprinosine in Patients With Severe AIDS

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

Primary conditionAcquired Immunodeficiency SyndromeRegistry: HIV InfectionsReclassifiedWhy we changed it
Registry
HIV Infections — the first condition term the registry derived for this study.
ClinicalTrials.gg
Acquired Immunodeficiency Syndrome
Why
  1. The study's title name Acquired Immunodeficiency Syndrome, a narrower term within HIV Infections.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

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

Where this study stands

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

Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.

No phase
642 of 1,670
59 open now
Registered
3rd of 1,670
by date

Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is one of 642 with no phase, and was the 3rd registered.

Acquired Immunodeficiency Syndrome

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:

106 more — sign in →

All 111 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 197 Acquired Immunodeficiency Syndrome studies recruiting now, 117 (59%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

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

The full table on the hub →

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02

Study summary

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.
03

Conditions studied

  • HIV Infections

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Keywords

  • Infusions, Intravenous
  • Drug Evaluation
  • Administration, Oral
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Zidovudine
  • Biological Availability
04

In context

Acquired Immunodeficiency Syndrome Reclassified

3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Newport Pharmaceuticals International is the lead sponsor of 6 studies on the registry; none are open to participants now.

Compared within Acquired Immunodeficiency Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

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

Eligibility 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:

  • .
  • Cytotoxic 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.

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.

06

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double

Interventions

07

Study locations

1 site
  • Newport Pharmaceuticals International Inc
    Laguna Hills, California 92656, United States
08

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 ↗
09

Registry details

Key details

Study ID
NCT00002295
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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