A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inosine pranobex

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring T-Lymphocytes, Suppressor-Effector, Neoplasms, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Newport Pharmaceuticals International Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002059

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Newport Pharmaceuticals International

1. Study Identification

Unique Protocol Identification Number

NCT00002059

Brief Title

A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

Official Title

A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

June 1989

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Newport Pharmaceuticals International

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

T-Lymphocytes, Suppressor-Effector, Neoplasms, Inosine Pranobex, Killer Cells, T-Lymphocytes, Helper-Inducer, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

Double

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Inosine pranobex

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Facility Information:

Facility Name

Newport Pharmaceuticals International Inc

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92656

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial