A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Launched by HEM RESEARCH · Aug 30, 2001
Trial Information
Current as of July 03, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Hem Research
Hem Research is a pioneering clinical trial sponsor dedicated to advancing therapeutic innovations in hematology. With a focus on developing cutting-edge treatments for blood-related disorders, Hem Research employs a rigorous scientific approach and a commitment to patient-centered care. Our multidisciplinary team of experts collaborates with healthcare professionals, regulatory bodies, and patient advocacy groups to ensure the highest standards of research integrity and ethical compliance. By leveraging state-of-the-art technology and methodologies, Hem Research aims to accelerate the development of safe and effective therapies, ultimately improving patient outcomes and enhancing quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Miami, Florida, United States
Dallas, Texas, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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