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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002269
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002269 on ClinicalTrials.gov Archive Site
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A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

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.

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Interventional
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Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Ampligen
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002269
073A, AMP-700
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HEM Research
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NIH AIDS Clinical Trials Information Service
August 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP