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

H

HEM Research

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Ampligen
Drug: Zidovudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002269
AMP-700
073A

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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