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

NCT ID: NCT00002269

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ampligen

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HEM Research

INDUSTRY

Sponsor Role lead

Locations

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Miami Veterans Administration Med Ctr

Miami, Florida, United States

Site Status

Oregon Health Sciences Univ

Portland, Oregon, United States

Site Status

MCP Hahnemann Univ Hosp

Philadelphia, Pennsylvania, United States

Site Status

Nelson Tebedo Community Clinic

Dallas, Texas, United States

Site Status

Dr Patricia Salvato

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AMP-700

Identifier Type: -

Identifier Source: secondary_id

073A

Identifier Type: -

Identifier Source: org_study_id