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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
HEM Research


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002269

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1991
History of Changes
Purpose

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

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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
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

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

More Information


Responsible Party: HEM Research  
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  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
ampligen
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Zidovudine
poly(I).poly(c12,U)
Poly I-C

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.