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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
  Purpose

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 Intervention
HIV Infections
Drug: Ampligen
Drug: Zidovudine

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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002269

Locations
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002269     History of Changes
Other Study ID Numbers: 073A, AMP-700
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014