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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1
Univ of Pittsburgh Med School
Pittsburgh, Pennsylvania, United States