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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002060
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1989

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002060 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)
A Multi-Center Randomized Double-Blind Placebo-Controlled Study To Investigate the Effect of Isoprinosine in Patients With AIDS Related Complex (ARC)

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.

Not Provided
Interventional
Not Provided
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: Inosine pranobex
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.

Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002060
008D, ISO-111-USA
Not Provided
Not Provided
Newport Pharmaceuticals International
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP