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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002269

Run by

HEM Research

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Oregon Health Sciences Univ — Portland, Oregon, United States
• MCP Hahnemann Univ Hosp — Philadelphia, Pennsylvania, United States
• Nelson Tebedo Community Clinic — Dallas, Texas, United States
• Dr Patricia Salvato — Houston, Texas, United States

Full record on ClinicalTrials.gov

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