A Study of Isoprinosine in Patients With Severe AIDS

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

Eligibility Criteria

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

Exclusion Criteria Co-existing Condition: Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer are excluded. Concurrent Medication: Excluded: Steroids. Cytotoxic immunosuppressive 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.

Sites / Locations

Newport Pharmaceuticals International Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002295

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Newport Pharmaceuticals International

1. Study Identification

Unique Protocol Identification Number

NCT00002295

Brief Title

A Study of Isoprinosine in Patients With Severe AIDS

Official Title

A Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Severe Acquired Immunodeficiency Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

June 1989

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Newport Pharmaceuticals International

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

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

HIV Infections

Keywords

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

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

All

Minimum Age & Unit of Time

18 Years

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: Steroids. Cytotoxic immunosuppressive 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.

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