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

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

This study has been completed.

Study NCT00002269. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Official Title ^†	A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
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.
Detailed Description
Study Phase
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Ampligen Drug: Zidovudine
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†
Start Date ^†
Completion Date
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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002269
Organization ID	073A
Secondary IDs ^††	AMP-700
Study Sponsor ^†	HEM Research
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 1991
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.