---
title: The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
nct_id: NCT00002296
overall_status: COMPLETED
phase: NA
sponsor: Newport Pharmaceuticals International
study_type: INTERVENTIONAL
primary_condition: Lymphatic Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00002296.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00002296"
ct_last_update_post_date: 2005-06-24
last_seen_at: "2026-05-12T07:00:15.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease

**Official Title:** A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy

**NCT ID:** [NCT00002296](https://clinicaltrials.gov/study/NCT00002296)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Lead Sponsor:** Newport Pharmaceuticals International
- **Conditions:** Lymphatic Disease, HIV Infections
- **CT.gov Last Update:** 2005-06-24

## Brief 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 immunological parameters:

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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 malignancy.
* Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
* Heart disease (especially if receiving cardiac glycosides).
* Hemophilia.

Patients with the following are excluded:

* Kaposi's sarcoma or overt opportunistic infections as follows:
* Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
* 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.
* Hemophilia.

Prior Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Antiviral medicine.

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.
```

## Interventions

- **Inosine pranobex** (DRUG)

## Locations (1)

- Newport Pharmaceuticals International Inc, Laguna Hills, California, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.newport pharmaceuticals international inc|laguna hills|california|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00002296*  
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