HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, ampligen, AIDS-Related Complex, Zidovudine
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.
Interventions
DRUGAmpligen
DRUGZidovudine
Sponsors
HEM Research
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed