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Home > "A" Clinical Trials Conditions > A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen  A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
For Condition: HIV Infections
Status: Completed
Sponsor(s): HEM Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Nelson Tebedo Community Clinic
Dallas, Texas, 75219
United States
Oregon Health Sciences Univ
Portland, Oregon, 97201
United States
Dr Patricia Salvato
Houston, Texas, 77054
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102
United States
Additional Information:
Study ID Numbers: 073A; AMP-700
Study Start Date:
Record last reviewed: August 1991
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002269
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients with Late-Stage HIV Disease
2. An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients
3. Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN alfa-2b), and Ribavirin (RBV) Treatment in Patients with Hepatitis C and HIV Coinfection
4. A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients with AIDS
5. Immune Response to Influenza Vaccine in HIV-Infected Individuals
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
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