Status:

COMPLETED

A Phase I Clinical Trial To Evaluate the Toxicity, Antiviral and Immunomodulatory Effects of a Range of Doses of Ampligen in HIV-Infected Subjects

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To determine the safety of ampligen at several doses in HIV-infected patients who have not yet developed AIDS or advanced AIDS related complex (ARC). Biologic, antiviral, and immunologic effects will ...

Detailed Description

Evidence indicates that a long period with no symptoms follows infection with HIV. Individuals who are infected with the virus could benefit from therapy with a drug that acts to kill the virus or to ...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Short-course therapy (7 days) with oral acyclovir or ketoconazole.

Patients must have:

  • Evidence of HIV infection as measured by a confirmed positive antibody test.
  • A confirmed or pending HIV blood culture, and serum p24 antigen test.
  • The ELISA test confirmed by a licensed Western blot analysis if they are asymptomatic.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Aspirin or acetaminophen beyond 72 hours without contacting investigator.
  • Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).

Patients with the following are excluded:

  • AIDS.
  • AIDS related symptoms or with advanced ARC and < 200 CD4 cells/mm3 and at least two of the following:
  • Weight loss in excess of 10 lbs or 10 percent of body weight within a 6-month interval.
  • Temperature > 38.5 degrees C with or without night sweats, persisting for more than 14 consecutive days or more than 15 days in a 30-day interval.
  • Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days without definable cause.
  • Recurrent oral candidiasis as documented by morphology or by response to antifungal therapy.
  • Patients cannot have active oral candidiasis at the time of entry into the study; they must be free of candidiasis from baseline 1 to enrollment.
  • Multidermatomal herpes zoster within the past 2 years.
  • Hairy leukoplakia within the past 3 years.

Prior Medication:

Excluded within 14 days of study entry:

  • Other biologic response modifiers.
  • Corticosteroids.
  • Systemic antibiotics.
  • Excluded within 30 days of study entry:
  • Other antiretroviral agents.
  • Excluded within 60 days of study entry:
  • Ribavirin.
  • Zidovudine.

Concurrent neoplasms other than basal cell carcinoma of the skin.

Active drug or alcohol abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

October 1 1992

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00000713

End Date

October 1 1992

Last Update

November 3 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Univ of Pittsburgh Med School

Pittsburgh, Pennsylvania, United States