A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects
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ClinicalTrials.gov Identifier: NCT00215852 |
Recruitment Status
:
Terminated
First Posted
: September 22, 2005
Last Update Posted
: September 4, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | September 16, 2005 | |||
First Posted Date ICMJE | September 22, 2005 | |||
Last Update Posted Date | September 4, 2013 | |||
Study Start Date ICMJE | July 2005 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Gene expression analysis [ Time Frame: Days 0, 2, 5, 11, 12 and 16 ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00215852 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
CD4 Level [ Time Frame: Days 0, 11 and 16 ] | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Randomized, Dose-ranging Study of Alferon LDO in Asymptomatic HIV+ Subjects | |||
Official Title ICMJE | A Randomized, Dose-Ranging Study of Alferon® LDO [Low Dose Interferon Alfa-n3 (Human Leukocyte Derived)] in Asymptomatic HIV+ Subjects | |||
Brief Summary | To conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an immunomodulator in subjects with asymptomatic HIV-1 infection. The primary endpoints of the study will include an increase or upregulation in genes known to be mediators of interferon response. Secondary endpoints will include the absolute CD4 count and plasma HIV RNA levels. | |||
Detailed Description | This study will be an open-label, randomized outpatient study in HIV infected subjects using a range of doses of Alferon LDO. The first nine (9) patients enrolled will not be randomized. Instead, the first three (3) patients will receive 500 IU, the second three (3) patients will receive 1000 IU, and the final three (3) patients will receive 2000 IU. Once three (3) patients at a given dose level have received at least 8 doses without grade 3 toxicity, patients may be enrolled at the next higher dose level. Following enrollment of the first nine (9) patients, additional patients will be randomized to receive one of the three (3) dose levels of Alferon® LDO. The Alferon LDO (natural interferon alfa-n3) will be in a buffer solution and taken orally once each day for 10 consecutive days at doses equal to 500 IU, 1000 IU, or 2000 IU. Pretherapy baseline evaluations will be performed within the three (3) week period prior to randomization. Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 4, and 10 on study days 2, 5, and 11, respectively. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE | Drug: Alferon LDO
500 IU, taken orally each evening, for 10 consecutive days while holding in the mouth for at least 2 minutes prior to swallowing, for 10 daysday 5 of each 28 day cycle. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
17 | |||
Original Enrollment ICMJE |
60 | |||
Actual Study Completion Date | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00215852 | |||
Other Study ID Numbers ICMJE | LDO-101 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Hemispherx Biopharma | |||
Study Sponsor ICMJE | Hemispherx Biopharma | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Hemispherx Biopharma | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |