Skip to content

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002060
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

Sponsors

Newport Pharmaceuticals International
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026