Clinical trial · Interventional
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
NCT00002059CI-TRIAL-00000043completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inosine pranobex | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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: * Steroids. * Cytotoxic immunosuppressive 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.
References
Publications (0)
Data not yet available
No reference posted for this study.