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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ampligen
Zidovudine
Sponsored by
HEM Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Zidovudine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Miami Veterans Administration Med Ctr
  • Oregon Health Sciences Univ
  • MCP Hahnemann Univ Hosp
  • Nelson Tebedo Community Clinic
  • Dr Patricia Salvato

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
HEM Research
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1. Study Identification

Unique Protocol Identification Number
NCT00002269
Brief Title
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Official Title
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Study Type
Interventional

2. Study Status

Record Verification Date
August 1991
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
HEM Research

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ampligen
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Miami Veterans Administration Med Ctr
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
MCP Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Nelson Tebedo Community Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Dr Patricia Salvato
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

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

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