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NCT00002297 Clinical Trial

A Study of Isoprinosine in Patients With Lymph Node Disease

HIV Infections Clinical Trial

Official title:
A Multi-Center Double-Blind Placebo-Controlled Study to Investigate the Action of Isoprinosine (Inosiplex) in Patients With Unexplained Generalized Lymphadenopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002297
Other study ID # 008A
Secondary ID ISO-103-USA
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date June 1989
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. Variables to be examined will include:

Signs and symptoms:

- Lymphadenopathy.

- Fever.

- Weight loss.

- Occurrence of opportunistic infections.

Cell-mediated immune system parameters:

- T-helper cell (OKT4) numbers and proportions.

- T-suppressor cell (OKT8) numbers and proportions.

- Natural killer (NK) cell activity.

- Lymphocyte blastogenic response to phytohemagglutinin (PHA).

- Lymphocyte blastogenic response to pokeweed mitogen (PWM).

- Immunoglobulin (IgG, IgA, IgM, IgE, IgD) profile.

- Circulating immune complexes. Infections characteristically associated with AIDS, such as Candida albicans, Pneumocystis carinii pneumonia, Cytomegalovirus, Herpes simplex, Cryptococcus, Histoplasma, Toxoplasma, Cryptosporidium, Mycobacterium avium- intracellulare, Legionella, and Isospora.

Safety parameters:

- Blood chemistry including serum uric acid (PurposeA-12).

- Complete blood count (CBC).

- Platelet count.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Exclusion Criteria

Co-existing Condition:

Patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded.

Concurrent Medication:

Excluded:

- Systemic corticosteroids.

- Cytotoxic immunosuppressive agents.

- Radiotherapy.

Critically ill patients or those with CDC-defined AIDS are excluded.

Prior Medication:

Excluded within 1 month of study entry:

- Immunotherapy.

Patients with persistent generalized lymphadenopathy (PGL).

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inosine pranobex

Locations
Country Name City State
United States Newport Pharmaceuticals International Inc Laguna Hills California

Sponsors (1)
Lead Sponsor Collaborator
Newport Pharmaceuticals International

Country where clinical trial is conducted

United States, 

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