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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002269 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Ampligen Drug: Zidovudine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002269
Responsible Party
Study ID Numbers ^ICMJE	073A, AMP-700
Study Sponsor ^ICMJE	HEM Research
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	August 1991
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP