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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002269
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ampligen Drug: Zidovudine Not Applicable

Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Zidovudine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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.


  • Zidovudine (AZT).

Required at least 6 months prior to study entry:

  • Zidovudine (AZT).

Active drug abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002269

United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
United States, Oregon
Oregon Health Sciences Univ
Portland, Oregon, United States, 97201
United States, Pennsylvania
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Nelson Tebedo Community Clinic
Dallas, Texas, United States, 75219
Dr Patricia Salvato
Houston, Texas, United States, 77054
Sponsors and Collaborators
HEM Research Identifier: NCT00002269     History of Changes
Other Study ID Numbers: 073A
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 1991

Keywords provided by NIH AIDS Clinical Trials Information Service:
Acquired Immunodeficiency Syndrome
AIDS-Related Complex

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Poly I-C
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs