Expired Study
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Houston, Texas 77054


To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.


Inclusion Criteria Patients must have: - HIV-1 seropositivity. - Absolute number of T4 cells 100-300 cells/mm3. - Given informed consent. - Zidovudine (AZT) therapy for 6 months prior to study entry. - At least one of the listed HIV-related clinical symptoms or opportunistic infections: - weight loss > 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis > 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Evidence of AIDS. - Intercurrent acute medical disorder. Concurrent Medication: Excluded: - Chemotherapy for Kaposi's sarcoma (KS). - Aspirin. - Non-steroidal anti-inflammatory drugs. Patients with the following are excluded: - Inability to return for treatment and evaluation for 12 months. - Intercurrent acute medical disorder. - Evidence of AIDS. - Receiving chemotherapy for Kaposi's sarcoma (KS). - Unwilling or unable to give informed consent. Required: - Zidovudine (AZT). Required at least 6 months prior to study entry: - Zidovudine (AZT). Active drug abuse.

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Official Title:

A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Overall Status:


Study Phase:




Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Masking: Double-Blind, Primary Purpose: Treatmen

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Study Dates

Verification Date:August 1991
Last Changed Date:June 23, 2005
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Intervention Type:Drug

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:HEM Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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