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| Sponsor: | Hemispherx Biopharma |
|---|---|
| Information provided by: | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00215852 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Alferon LDO |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Dose-Ranging Study of Alferon® LDO [Low Dose Interferon Alfa-n3 (Human Leukocyte Derived)] in Asymptomatic HIV+ Subjects |
| Estimated Enrollment: | 60 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith M Faith | 215-988-0080 | judy@hemispherx.net |
| United States, Pennsylvania | |
| Drexel University School of Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Henry Ming-Yow Wu, M.D 215-762-3489 Peter.Pitsakis@DrexelMed.edu | |
| Contact: Peter Pitsakis 215-762-3489 Peter.Pitsakis@DrexelMed.edu | |
| Philadelphia FIGHTS | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Karam Mounzer, MD 215-985-4448 ext 226 | |
| Contact: Cecile Gallo 215-985-4448 ext 226 cecile@fight.org | |
More Information
| Study ID Numbers: | LDO-101 |
| Study First Received: | September 16, 2005 |
| Last Updated: | October 21, 2005 |
| ClinicalTrials.gov Identifier: | NCT00215852 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alferon LDO Low Dose Oral Interferon Alfa-n3 Human Leukocyte Derived |
HIV Asymptomatic HIV Treatment Experienced |
|
Interferon-alpha Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immunologic Factors Immune System Diseases Physiological Effects of Drugs Acquired Immunodeficiency Syndrome Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |