A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

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 AIDS-Related Opportunistic Infections, Inosine Pranobex, Homosexuality, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Exclusion Criteria Concurrent Medication: Excluded: Cardiac glycosides. Patients with the following are excluded: AIDS. Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or > 3 months who have not responded to therapy. Critical illness. Hemophilia. Prior Medication: Excluded within 1 month of study entry: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy and/or systemic antiviral medication. Immunomodulators (including Isoprinosine). Prior Treatment: Excluded within 1 month of study entry: Radiotherapy. History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction. Lymphoid malignancy. Homosexual male patients with AIDS related complex (ARC). Current IV drug abuse.

Sites / Locations

Newport Pharmaceuticals International Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002060

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Newport Pharmaceuticals International

1. Study Identification

Unique Protocol Identification Number

NCT00002060

Brief Title

A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

Official Title

A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

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 is to determine the effect of Isoprinosine (inosine pranobex) in homosexual male patients with AIDS related complex (ARC) in delaying the onset of AIDS. Secondly, to determine the effect of Isoprinosine in decreasing the severity and/or incidence of lesser opportunistic infections and/or other conditions associated with ARC.

6. Conditions and Keywords

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

HIV Infections

Keywords

AIDS-Related Opportunistic Infections, Inosine Pranobex, Homosexuality, 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

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Exclusion Criteria Concurrent Medication: Excluded: Cardiac glycosides. Patients with the following are excluded: AIDS. Presenting with chronic candida infection-colo/rectal, oral/pharyngeal, cutaneous (finger/toenails) - for = or > 3 months who have not responded to therapy. Critical illness. Hemophilia. Prior Medication: Excluded within 1 month of study entry: Steroids. Cytotoxic immunosuppressive agents. Radiotherapy and/or systemic antiviral medication. Immunomodulators (including Isoprinosine). Prior Treatment: Excluded within 1 month of study entry: Radiotherapy. History of gout, uric acid urolithiasis, uric acid nephrolithiasis, or renal dysfunction. Lymphoid malignancy. Homosexual male patients with AIDS related complex (ARC). Current IV drug abuse.

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